A randomized multicenter Phase II trial evaluating oral pooled fecal microbiotherapy (MaaT033) concomitant to Cemiplimab (CB) versus best investigator’s choice (BIC) in resistance to PD-1/PD-L1 blockade due to antibiotics (ATB) uptake in patients with advanced non-small cell lung cancer (NSCLC) - IMMUNOLIFE2

2024-517018-14-00 Protocol 2024/3967 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 17 Nov 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 14 sites · Protocol 2024/3967

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 162
Countries 1
Sites 14

Advanced non-small cell lung cancer

To evaluate whether combination of MaaT033 and CB can enhance the disease control rate (DCR) at 12 weeks compared to BIC in ATB-related immune-checkpoint inhibitors (ICI)-refractory patients with advanced NSCLC. Confirmation of response must be demonstrated with an assessment 4-8 weeks from the initial response assess…

Key facts

Sponsor
Institut Gustave Roussy
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
17 Nov 2025 → ongoing
Decision date (initial)
2025-04-11
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
RHU · PHRC · REGENERON

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To evaluate whether combination of MaaT033 and CB can enhance the disease control rate (DCR) at 12 weeks compared to BIC in ATB-related immune-checkpoint inhibitors (ICI)-refractory patients with advanced NSCLC. Confirmation of response must be demonstrated with an assessment 4-8 weeks from the initial response assessment.

Secondary objectives 6

  1. To evaluate whether combination of MaaT033 and CB can increase the ORR compared to BIC
  2. To evaluate whether combination of MaaT033 and CB can increase PFS compared to BIC
  3. To velauate whether combination of MaaT033 and CB can increase OS compared to BIC.
  4. To evaluate whether combination of MaaT033 and CB can increase duration of response (DoR), defined as the time from the first confirmed patient response (CR and PR) to progression or death from any cause. Confirmation of response must be demonstrated with an assessment 4-8 weeks from the initial response assessment.
  5. The effect(s) of the combination of MaaT033 and CB versus BIC on the composition of gut microbiota, on blood inflammation parameters, on systemic and tumor immunity (blood and tumor deposits), and on systemic metabolism during treatment period (at baseline (before cycle 1), before cycles 3, 5, 7, 9, and again at months 12 and 24 after randomization), and at the end of treatment visit (after treatment discontinuation regardless of the reason for discontinuation). Sampling will be performed before each cycle as follows: prior to 1st dose of MaaT033 and prior to first dose of CB for arm A and prior to BIC for arm B.
  6. To identify pathophysiological surrogates of a successful MaaT033 engraftment and restoration of the ORR among a rich multi-omics database (metagenomics, metabolomics, immunomics/inflammation, epithelial/endothelial barrier markers).

Conditions and MedDRA coding

Advanced non-small cell lung cancer

VersionLevelCodeTermSystem organ class
27.1 PT 10061873 Non-small cell lung cancer 100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 16

  1. Participants who are at least 18 years of age on the day of signing informed consent
  2. Patients must be affiliated to a social security system or beneficiary of the same
  3. Have an estimated life expectancy greater than 3 months (from inclusion).
  4. Meet acceptable steroid dose thresholds (i.e., not above the acceptable threshold <10 mg prednisone daily or equivalent) if receiving systemic steroids at physiologic doses
  5. Have measurable disease based on RECIST 1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  6. Have adequate organ function as defined in the Table 1 on the protocol. All screening laboratory tests must be performed within 28 days prior to the start of study treatment.
  7. Histologically confirmed diagnosis of NSCLC (adenocarcinoma versus squamous cell carcinoma versus others)
  8. Have metastatic or unresectable NSCLC and considered by their physician to be indicated for a new line of immunotherapy.
  9. Have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 2. Evaluation of ECOG-PS is to be performed within 7 days prior to the date of treatment allocation.
  10. Patients who have progressed after immunotherapy or immunotherapy plus platinum-based chemotherapy (with platinum-based chemotherapy and ICI either sequentially or concomitantly).
  11. Have received ATB within 60 days before and 42 days after the first ICI administration and have progressed within 6 months after the first ICI.
  12. A male participant must abstain from heterosexual activity or must agree to use a contraception as detailed below (or in Appendix 2 of this protocol) during the treatment period and for at least 9 months after the last dose of CB or BIC and refrain from donating sperm during this period. (In application of the new recommendations of the CTFG)
  13. A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and if at least one of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) as defined in Appendix 2. b) A WOCBP should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A WOCBP must agree to follow the contraceptive guidance in Appendix 2 or abstain from heterosexual activity during the treatment period and for at least 180 days, after the last dose of treatment
  14. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  15. All participants must understand spoken and written national language
  16. There are no restrictions on the number of prior lines of treatment. Patients may be included regardless of the number of previous therapies received

Exclusion criteria 16

  1. Immunodeficiency or systemic steroid therapy equivalent to prednisolone >10mg/day or equivalent within 7 days prior to the first dose of trial treatment.
  2. Active ongoing infection requiring ATB treatment.
  3. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  4. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
  5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
  6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Participants who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent and that all study drug-related AEs have resolved to grade 1 or less.
  7. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  8. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  9. Has a known history of Human Immunodeficiency Virus (HIV).
  10. Has a known history of Hepatitis B virus (HBV, defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (HCV, considered active if HCV RNA is detected) infection. Note: no testing for HBV and HCV is required unless mandated by local health authority.
  11. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  12. Any condition which, in the Investigator’s opinion, makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol.
  13. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
  14. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of treatment.
  15. Persistent toxicities related to prior treatment of grade greater than 1.
  16. Swallowing disorders which can affect the intake of the oral pooled fecal microbiotherapy (MaaT033).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. To evaluate whether combination of MaaT033 and CB can enhance DCR at weeks 12 as per the RECIST 1.1 criteria compared to BIC. The DCR is defined as the percentage of patients achieving complete response (CR), partial response (PR) or stable disease (SD) using RECIST v1.1 criteria. Confirmation of response must be demonstrated with an assessment 4-8 weeks from the initial response assessment (iRECIST).

Secondary endpoints 7

  1. To evaluate Whether combination of MaaT033 and CB can increase DCR/ORR at 12, 24, 36 and 60 months. The ORR is defined as the rate of CR or PR as per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
  2. To evaluate whether combination of MaaT033 and CB can increase PFS. The PFS is defined as the time from random assignment to the progression, or death due to any cause, whichever occurs first.
  3. To evaluate whether combination of MaaT033 and CB can increase OS. The OS is defined as the time from random assignment to the date of death due to any cause, or to the date of censoring at the last time the subject was known to be alive
  4. Whether combination of MaaT033 and CB can increase the DoR. The DoR is defined as the time from the first confirmed patient response (CR or PR) to disease progression (or death from any cause).
  5. Incidence of AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), death, and laboratory abnormalities related to MaaT033 and CB versus BIC, using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0. Safety parameters include all SAEs or non-serious adverse events (AEs) and deaths graded using the NCI-CTCAE v5.0 (Common Terminology Criteria for AEs).
  6. To evaluate the effect(s) of the combination of MaaT033 and CB versus BIC on the composition of gut microbiota, on blood inflammation parameters, on systemic and tumor immunity (blood and tumor deposits), and on systemic and gut metabolism at baseline prior to 1st dose of MaaT033, prior to first dose of CB, at weeks 12 and 24 during treatment period, and again at months 12 and 24 after randomization.
  7. To identify pathophysiological surrogates of a successful MaaT033 and restoration of the ORR among a rich multi-omics database (metagenomics, metabolomics, immunomics/inflammation, epithelial/endothelial barrier markers).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

MaaT033

PRD8529751 · Product

Active substance
Allogeneic Faecal Microbiota, Pooled
Pharmaceutical form
PROLONGED-RELEASE CAPSULE
Route of administration
ORAL
Max daily dose
1.26 g gram(s)
Max total dose
79.38 g gram(s)
Max treatment duration
6 Month(s)
Authorisation status
Not Authorised
MA holder
MAAT PHARMA
Paediatric formulation
No
Orphan designation
No

LIBTAYO 350 mg concentrate for solution for infusion.

PRD7478447 · Product

Active substance
Cemiplimab
Substance synonyms
REGN2810
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
350 mg milligram(s)
Max total dose
12250 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01XC33 — -
Marketing authorisation
EU/1/19/1376/001
MA holder
REGENERON IRELAND D.A.C.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 35

Pemetrexed

SUB09655MIG · Substance

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
2000 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed

SUB09655MIG · Substance

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
2000 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed

SUB09655MIG · Substance

Active substance
Pemetrexed
Pharmaceutical form
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
2000 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed

SUB09655MIG · Substance

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
2000 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed

SUB09655MIG · Substance

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
2000 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed

SUB09655MIG · Substance

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
2000 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed

SUB09655MIG · Substance

Active substance
Pemetrexed
Pharmaceutical form
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
2000 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed

SUB09655MIG · Substance

Active substance
Pemetrexed
Pharmaceutical form
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
2000 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine

SUB07892MIG · Substance

Active substance
Gemcitabine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
1250 mg/m2 milligram(s)/square meter
Max total dose
2500 mg/m2 milligram(s)/square meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine

SUB07892MIG · Substance

Active substance
Gemcitabine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
1250 mg/m2 milligram(s)/sq. meter
Max total dose
2500 mg/m2 milligram(s)/sq. meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine

SUB07892MIG · Substance

Active substance
Gemcitabine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
1250 mg/m2 milligram(s)/sq. meter
Max total dose
2500 mg/m2 milligram(s)/sq. meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine

SUB07892MIG · Substance

Active substance
Gemcitabine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
1250 mg/m2 milligram(s)/sq. meter
Max total dose
2500 mg/m2 milligram(s)/sq. meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vinorelbine

SUB00069MIG · Substance

Active substance
Vinorelbine
Pharmaceutical form
CAPSULE, SOFT
Route of administration
ORAL USE
Max daily dose
80 mg milligram(s)
Max total dose
240 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vinorelbine

SUB00069MIG · Substance

Active substance
Vinorelbine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
60 mg/m2 milligram(s)/sq. meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vinorelbine

SUB00069MIG · Substance

Active substance
Vinorelbine
Pharmaceutical form
CAPSULE, SOFT
Route of administration
ORAL USE
Max daily dose
80 mg milligram(s)
Max total dose
240 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vinorelbine

SUB00069MIG · Substance

Active substance
Vinorelbine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
60 mg/m2 milligram(s)/sq. meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel

SUB09583MIG · Substance

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
175 mg/m2 milligram(s)/sq. meter
Max total dose
240 mg/m2 milligram(s)/sq. meter
Max treatment duration
28 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel

SUB09583MIG · Substance

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
175 mg/m2 milligram(s)/sq. meter
Max total dose
240 mg/m2 milligram(s)/sq. meter
Max treatment duration
28 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel

SUB09583MIG · Substance

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
175 mg/m2 milligram(s)/sq. meter
Max total dose
240 mg/m2 milligram(s)/sq. meter
Max treatment duration
28 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel

SUB09583MIG · Substance

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
175 mg/m2 milligram(s)/sq. meter
Max total dose
240 mg/m2 milligram(s)/sq. meter
Max treatment duration
28 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel

SUB09583MIG · Substance

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
240 mg/m2 milligram(s)/square meter
Max treatment duration
28 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Docetaxel

SUB12492MIG · Substance

Active substance
Docetaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
200 mg/m2 milligram(s)/sq. meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Docetaxel

SUB12492MIG · Substance

Active substance
Docetaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
200 mg/m2 milligram(s)/sq. meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Docetaxel

SUB12492MIG · Substance

Active substance
Docetaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
200 mg/m2 milligram(s)/sq. meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Docetaxel

SUB12492MIG · Substance

Active substance
Docetaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
200 mg/m2 milligram(s)/sq. meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
735 mg milligram(s)
Max total dose
4410 mg milligram(s)
Max treatment duration
126 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
735 mg milligram(s)
Max total dose
4410 mg milligram(s)
Max treatment duration
126 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
735 mg milligram(s)
Max total dose
4410 mg milligram(s)
Max treatment duration
126 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
SOLUTION FOR INFUSION
Max daily dose
735 mg milligram(s)
Max total dose
4410 mg milligram(s)
Max treatment duration
126 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bevacizumab

SUB16402MIG · Substance

Active substance
Bevacizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
15 mg/Kg milligram(s)/kilogram
Max total dose
60 mg/Kg milligram(s)/kilogram
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bevacizumab

SUB16402MIG · Substance

Active substance
Bevacizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
15 mg/kg milligram(s)/kilogram
Max total dose
60 mg/kg milligram(s)/kilogram
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
400 mg/m2 milligram(s)/square meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
400 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
400 mg/m2 milligram(s)/sq. meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin

SUB07483MIG · Substance

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
100 mg/m2 milligram(s)/square meter
Max total dose
400 mg/m2 milligram(s)/square meter
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Gustave Roussy

48 Total trials 31 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Institut Gustave Roussy
Address
114 Rue Edouard Vaillant
City
Villejuif
Postcode
94800
Country
France

Scientific contact point

Organisation
Institut Gustave Roussy
Contact name
Regulatory Affairs Officer

Public contact point

Organisation
Institut Gustave Roussy
Contact name
Regulatory Affairs Officer

Locations

1 EU/EEA country · 14 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 162 14
Rest of world — 0 —

Investigational sites

France

14 sites · Ongoing, recruiting
Scp Institut De Cancerologie Des Hauts De France
oncology-Radiologist, Centre Pierre Curie, 2 Rue Delbecque, Beuvry
Assistance Publique Hopitaux De Paris
medical oncology, 1 Avenue Claude Vellefaux, 75010, Paris
Hopital Europeen Marseille
pneumology, 6 Rue Desiree Clary, 13003, Marseille
Centre Hospitalier Universitaire Grenoble Alpes
Penumology - Thoracic oncology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Assistance Publique Hopitaux De Paris
thoracic oncology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Hopital Cochin - Port Royal
oncology, 123 bd de Port Royal, 75014, PARIS
Centre Hospitalier Regional De Marseille
oncology, 265 Chemin Des Bourrely, 13015, Marseille
Institut Gustave Roussy
cancer immulogy, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Paoli Calmettes
oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
pneumology oncology, 54 Rue Henri Sainte Claire Deville, 83100, Toulon
Centr Georges Francois Leclerc
oncology, 1 Rue Professeur Marion, 21000, Dijon
Hospital Foch
penumology, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Respiratory Diseases Service, Avenue Des Tamaris, 13100, Aix En Provence
Assistance Publique Hopitaux De Paris
Pneumology - Thoracic oncology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2025-11-17 2025-12-02

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol IMMUNOLIFE2_2024-517018-14-00_biffe 1.2
Protocol (for publication) D4_Patient Diary_biffe 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements NA
Recruitment arrangements (for publication) K2_Document additionnel_IMMUNOLIFE2_biffe NA
Subject information and informed consent form (for publication) K1_Recruitment arrangements NA
Subject information and informed consent form (for publication) L1_ICF 1.2
Subject information and informed consent form (for publication) L1_ICF_Partenaires enceintes 1.1
Subject information and informed consent form (for publication) L1_SIS_biffe 1.2
Subject information and informed consent form (for publication) L1_SIS_Partenaires enceintes 1.1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Bevacizumab_FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Carboplatine_FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cemiplimab_FR NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cisplatine_solution a diluer pour perfusion_FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Docetaxel_FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Gemcitabine _FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Paclitaxel_FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pemetrexed_poudre pour infusion_FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pemetrexed_solution pour infusion_FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Vinorelbine capsule molle_FR 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Vinorelbine10 mg_1 ml solution injectable en flacon_FR 1
Synopsis of the protocol (for publication) D1_Protocol Synopsis IMMUNOLIFE2 FR_2024-517018-14-00_biffe 1.2

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-12-18 France Acceptable
2025-04-07
 2025-04-11
2 SUBSTANTIAL MODIFICATION SM-1 2025-07-11 France Acceptable
2025-09-22
 2025-09-22

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