"Study of chemotherapy vs immunotherapy for patients with lung cancer bounded in the thorax and completely resected"

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion GECP

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 Jan 2021 → ongoing

Decision date (initial)

2024-05-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fundación GECP

External identifiers

EU CT number

2024-513730-38-00

EudraCT number

2020-002088-71

ClinicalTrials.gov

NCT04564157

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time

Secondary objectives 2

1. 1. Overall survival
2. 2. Safety and tolerability: Adverse events graded according to CTCAE v5.0

Conditions and MedDRA coding

Resectable Non-small cell lung cancer

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. 1. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed.
2. 2. Patients should be classified postoperatively in stage IB (=4cm), II or IIIA according to pathological criteria and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
3. 3. Complete surgical resection of the primary NSCLC is also essential. Surgeons are strongly advised to dissect of all accessible lymph node levels, as established in the European Society of Thoracic Surgeons guide. Consequently, at the end of the surgical intervention it is recommended to have dissected of a minimum of 3 specific mediastinal gan-glionic lobe stations (N2), one of which should include station 7, and at least threeN1 lymph nodes (including those resected with the tumor piece)
4. 4. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneu-monectomy, as determined by the responsible surgeon based on intraoperative findings. Patients who have had only segmentectomies or wedge resections are not considered eligible for participation in this study except if R0 resection can be confirmed.
5. 5. Preoperative (neoadjuvant) use of platinum-based chemotherapy or other types of chemotherapy are not accepted.
6. 6. Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible.
7. 7. A minimum of 3 weeks must have elapsed between the surgical intervention performed for the NSCLC and the randomization. Adjuvant treatment must start between the 3rd and the 10th week from surgery.
8. 8. ECOG 0-1
9. 9. Patients aged ≥ 18 years
10. 10. Correct hematological, hepatic and renal function
11. 11. Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements
12. 12. Patients must be accessible for treatment and follow-up
13. 13. Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before randomization.
14. 14. All sexually active men and women of childbearing potential must use a highly effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 5 months for females and 7 months for males following the last administration of trial drugs

Exclusion criteria 15

1. 1. Patients with a history of other malignant diseases, with the exception of the following: or properly treated non-melanotic skin cancer or cancer in situ treated with curative intent or other malignancies treated with curative intent and without signs of disease for a period of> 3 years after the end of the treatment and which, in the opinion of the doctor in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease
2. 2. Patients with ALK, STKB11 o KEAP1 known mutations before inclusion in this trial
3. 3. Patients with adenocarcinoma NSCLC must be tested for the common EGFR mutations before inclusion. Patients with any known EGFR mutation cannot be enrolled in the study
4. 4. Patients with a combination of microcytic and non-small cell lung cancer, a carcinoid lung tumor
5. 5. Patients that received live attenuated vaccines within 30 days prior to randomization
6. 6. History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments
7. 7. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol
8. 8. Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, mycardial infarction in the previous year or ventricular cardiac arrhythmias that require medication, history of atrioventricular conduction of second or third degree). Patients with relevant cardiac history, even when well controlled, should have a LVEF> 50% in the 12 weeks prior to randomization
9. 9. Pregnant or breastfeeding women
10. 10. Patients in whom R0 resection cannot be confirmed
11. 11. Partients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
12. 12. Partients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
13. 13. Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g. Hepatitis B surface antigen (HbsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative)
14. 14. History of allergy or hypersensitivity to any of the study drug components
15. 15. Prior anti-PD1/L1 treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

Secondary endpoints 2

1. Overall survival (OS): defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive
2. Safety and tolerability: will be measured by incidence of AE, SAE, immune-related AEs, deaths, and laboratory abnormalities. Adverse events will be graded according to CTCAE v5.0

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion GECP

Sponsor organisation

Fundacion GECP

Address

Avinguda Meridiana 358 6 Planta

City

Barcelona

Postcode

08027

Country

Spain

Scientific contact point

Organisation

Fundacion GECP

Contact name

Mariano Provencio

Public contact point

Organisation

Fundacion GECP

Contact name

Maria Fernández

Locations

1 EU/EEA country · 30 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 4 files

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

Application history

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