Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Carboplatin

Vaccines

Pemetrexed

Cisplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks

TG4010

Pemetrexed/Cisplatin or Carboplatin

Pemetrexed maintenance

Chemotherapy

This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and with \< 50% of tumor cells expressing programmed death-ligand 1 (PD-L1) by immunohistochemical (IHC) staining.

A Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With the Therapeutic Vaccine Named TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

A Phase II Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

Percentage of participants whose best overall response is complete response or partial response using RECIST 1.1. confirmed by a second scan no less than 4 weeks after the criteria for response are first met.

Complete response: disappearance of all lesions and no new lesions. Partial response: decrease of at least 30% in the sum of the diameters of measurable lesions taking as reference the baseline sum of diameters, no progression of non-measurable lesions and no new lesions.

Time from the date of the first study drug administration to the date of first documented tumor progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

The Kaplan-Meier estimator was used to estimate median PFS and its confidence interval.

Percentage of participants whose best overall response is either complete response, partial response or stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions and no measurable non-target lesions; Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD).

Overall Survival (OS) is defined as the time from the first study drug administration to the date of death due to any cause.

The Kaplan-Meier estimator was used to estimate median OS and its confidence interval.

Time from first documented response (complete response or partial response) until documented disease progression or death due to lung cancer.

The assessment of safety of the combination was based mainly on the frequency of adverse events, serious adverse events, adverse events of special interest (Injection site reaction, fatigue, pyrexia, infusion-related reactions and diarrhea), immune-mediated adverse events and laboratories abnormalities.

Bristol-Myers Squibb

Transgene

TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks

Chemotherapy: Pemetrexed/Cisplatin or Carboplatin

Pemetrexed maintenance

Nivolumab: 360 mg IV administration every 3 weeks

TG4010/Chemotherapy/Nivolumab

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Belgium

Hungary

United States

France

Region of Enrollment

ECOG PS 0

ECOG PS 1

ECOG PS 0: Fully active, able to carry on all pre-disease performance without restriction ECOG PS 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

Body Mass Index (BMI)

Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay (method Dako PD-L1 IHC 22C3 pharmDx assay kit) using tumor tissue from an archival or newly obtained biopsy. Participants with PD-L1 expression ≤50% of tumor cells were eligible to the study.

PD-L1 percentage of stained cells

Director of Medical Affairs

The Evaluable Patient's Population is the primary population for efficacy analyses. Evaluable Patient's Population consists of all participants without major protocol deviation and have at least one baseline and one post-baseline evaluable CT-scan after study treatment start except early disease progression and death due to lung cancer.

Objective Response Rate (ORR)

Progression Free Survival (PFS)

Disease Control Rate (DCR)

Overall Survival

Responders: all evaluable participants with complete response or partial response. The start date was the date of first documented response (complete response or partial response) and the end date was the date of first documented disease progression. If no progression has been observed at the cut-off date of analysis or at the date when a subsequent cancer therapy was started, duration of response was censored at the date of the last evaluable tumor assessment.

Spots Global Cancer Trial Database for A Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With the Therapeutic Vaccine Named TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial