Study of chemotherapy and immunotherapy for patients with lung cancer bounded in the thorax and potentially resectable

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

14 May 2019 → 2 Apr 2026

Decision date (initial)

2024-06-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fundación GECP

External identifiers

EU CT number

2024-513731-24-00

EudraCT number

2018-004515-45

ClinicalTrials.gov

NCT03838159

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

The primary objective is pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-inmunotherapy versus chemotherapy alone.

Secondary objectives 10

1. 1. Overall survival
2. 2.Progression-free survival
3. 3. Major pathological response rate
4. 4. Downstaging
5. 5. Portion of delayed/canceled surgeries, length of hospital stays, surgical approach, incidence of AE/SAE related to surgery
6. 6. Mortality at 90 days after surgery
7. 7. Safety and tolerability: Adverse events graded according to CTCAE v5.0
8. 8. Biomarker endpoints
9. 9. To determine the association between MPR and histology
10. 10. To determine the association of the histology with the progression free survival at 18 months

Conditions and MedDRA coding

Non-small cell lung cancer (NSCLC)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 1. Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients’ stage IIIB with T3N2 disease according to 8th edition can be included
2. 2. Tumor should be considered resectable before study entry by a multidisciplinary team
3. 3. ECOG (Performance status) 0-1
4. 4. Correct hematological, hepatic and renal function
5. 5. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any
6. 6. Patients aged > 18 years
7. 7. 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 7 days before beginning of chemotherapy
8. 8. All sexually active men and women of childbearing potential must use an effective contraceptive method during the study treatment and for a period of at least 12 months following the last administration of trial drugs
9. 9. Patient capable of proper therapeutic compliance and accessible for correct follow-up
10. 10. Measurable or evaluable disease (according to RECIST 1.1 criteria)

Exclusion criteria 13

1. 1. All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene
2. 2. Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included
3. 3. Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
4. 4. Patients with a history of interstitial lung disease cannot be included if they have sympthomatic ILD (Grade 3-4) and/or poor lung function.
5. 5. Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anticancer therapy
6. 6. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
7. 7. Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
8. 8. Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
9. 9. Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
10. 10. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
11. 11. Patients with history of allergy to study drug components excipients
12. 12. Women who are pregnant or in the period of breastfeeding
13. 13. Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pathological Complete Response (pCR)

Secondary endpoints 10

1. 1. Overall survival
2. 2.Progression-free survival
3. 3. Major pathological response rate
4. 4. Downstaging
5. 5. Portion of delayed/canceled surgeries, length of hospital stays, surgical approach, incidence of AE/SAE related to surgery
6. 6. Mortality at 90 days after surgery
7. 7. Safety and tolerability: Adverse events graded according to CTCAE v5.0
8. 8. Biomarker endpoints
9. 9. To determine the association between MPR and histology
10. 10. To determine the association of the histology with the progression free survival at 18 months

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 · 25 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

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