A clinical study evaluating nivolumab-containing treatments in patients with advanced non-small cell lung cancer after failing previous PD-[L]1 therapy and chemotherapy

Phase 1

Conditions: Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) after Failure of Platinum- Based Chemotherapy and Anti-PD-1 (L1) Immunotherapy
MedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-004283-65-NO

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 550

Inclusion Criteria

- histologically or cytologically-documented Stage IV A/B non-small cell lung cancer, stage IIIB/C disease failed concurrent chemoRT
- ECOG Performance Status of = 1
- Radiographically documented disease progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen given either concurrently or sequentially within 90 days after the last dose of anti-LD-(L)1
- All participants must have tumor tissue submitted prior to randomization, either a recent archival sample obtained on/after
the date of disease progression of the last prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy obtained
during the screening period.
- Prior toxicities must have resolved to grade =1
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and must not be breastfeeding
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception. In addition, male participants must be willing to refrain from sperm donation during this time and must agree to follow instructions for method(s) of contraception. Azoospermic males are exempt from contraceptive requirements as well as WOCBP who are continuously not heterosexually active, however, a pregnancy test will still be required.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 275
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 275

Exclusion Criteria

- Prior treatment with Docetaxel
- Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases
- Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea
- EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy
- History of cerebrovascular accident and coagulation disorders
- Participants with interstital lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization
- Known toxicity on prior checkpoint inhibitor treatment
- Participants who received more than one line of anti- PD-1/PD-L1 treatment
- Participants who received previous CTLA-4 inhibitor treatment
- Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate objective response rate (ORR) of nivolumab-containing combination regimens vs docetaxel control arm;Secondary Objective: - To evaluate overall survival (OS) of nivolumab-containing combination regimens vs docetaxel control arm<br>- To evaluate progression-free survival (PFS) of nivolumab-containing combination regimens vs docetaxel control arm<br>-To evaluate duration of response (DOR) of nivolumab-containing combination regimens vs docetaxel control arm<br>- To evaluate the safety and tolerability of the different treatment regimens;Primary end point(s): Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment;Timepoint(s) of evaluation of this end point: Approximatively 33 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Overall Survival (OS)<br>- Duration of Response (DOR) by BIRC using RECIST 1.1<br>- Progression-Free Survival (PFS) by BICR using RECIST 1.1<br>- Incidence of Adverse Events (AEs)<br>- Incidence of Serious Adverse Events (SAEs)<br>- Incidence of Select AEs;Timepoint(s) of evaluation of this end point: - Up to 5 Years<br>- Approximatively 33 months<br>- Up to 5 Years<br>- Up to 5 Years<br>- Up to 5 Years<br>- Up to 5 Years

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