Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Death

Camurati-Engelmann Disease

All Drugs and Chemicals

Mitogens

Participants who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) per dose in a parent protocol, will receive an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Participants who are entering the rollover study after discontinuation of treatment in a parent study will receive bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.

Bintrafusp alfa

Medical Responsible

This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT03840902, NCT02699515, NCT04246489, NCT04489940, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) and to collect long-term safety and efficacy data.

Study Duration: All participants in this rollover study will be treated with bintrafusp alfa until meeting defined criteria in the protocol for discontinuation, until study intervention is commercially accessible and provisioned via marketed product, or until end of study.

The study also includes a 5 years survival follow-up after last dose of the study treatment.

Treatment Duration: Treatment under the rollover protocol according to the interval and dosing schedule in the parent protocol until discontinuation.

Bintrafusp Alfa Program Rollover Study

An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Bintrafusp Alfa (M7824) Clinical Studies

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Merck KGaA, Darmstadt, Germany

EMD Serono Research & Development Institute, Inc.

Carcinoma, Non-Small-Cell Lung

Recurrence

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Pembrolizumab

Cisplatin

Dostarlimab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Participants will receive pembrolizumab with or without PBCD.

Participants will receive dostarlimab with or without PBCD.

PBCD consisting of pemetrexed+ (carboplatin or cisplatin) will be administered.

Pemetrexed+ (carboplatin or cisplatin)

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Eleni Karapanagiotou

The goal of this clinical trial is to investigate the utility of two biomarker tools: Patient-derived organoid (PDOs) and PDL1 PET imaging for predicting how participants with recurrent NSCLC respond to standard of care treatment in the advanced/metastatic stages.

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Patient-derived Organoids and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

A Pilot/Exploratory Translational Study to Evaluate Response to Dostarlimab and Pembrolizumab in Patient-derived Organoids and by Zirconium-89 Labelled Programmed Death Ligand 1 Positron Emission Tomography in Participants With Recurrent Non-small Cell Lung Cancer

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

The primary endpoint is the correlation between "treatment-induced change in PDL1 in PDOs which will be evaluated as the ratio of PDL1 positive cells before and after treatment using flow cytometry and multiplex immunofluorescence analysis" AND "changes in PET which will be evaluated as the percentage difference in PDL1-PET standard uptake volume (SUV) uptake in lesions from the baseline to on-treatment" using the formula for Spearman's rank correlation coefficient. The Spearman's rank correlation coefficient can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association and a value of -1 indicates a perfect negative association.

The secondary endpoint is the correlation between "treatment-induced change in PDL1 in PDOs which will be evaluated as the ratio of PDL1 positive cells before and after treatment using flow cytometry and multiplex immunofluorescence analysis" AND "tumor response rate which will be assessed based on RECIST v1.1 per investigator assessment" using the formula for Spearman's rank correlation coefficient. The Spearman's rank correlation coefficient can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association and a value of -1 indicates a perfect negative association.

The secondary endpoint is the correlation between "changes in PET which will be evaluated as the percentage difference in PDL1-PET standard uptake volume (SUV) uptake in lesions from the baseline to on-treatment" AND "tumor response rate which will be assessed based on RECIST v1.1 per investigator assessment" using the formula for Spearman's rank correlation coefficient. The Spearman's rank correlation coefficient can take values from +1 to -1 where a value of +1 indicates a perfect association, a value of 0 indicates no association and a value of -1 indicates a perfect negative association.

GlaxoSmithKline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bintrafusp Alfa Program Rollover Study	NCT05061823	Lung Cancer Cancer	Bintrafusp alfa	18 Years -	EMD Serono
Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Patient-derived Organoids and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)	NCT06405230	Lung Cancer, No...	Pembrolizumab Dostarlimab Pemetrexed+ (ca...	30 Years -	GlaxoSmithKline
Bintrafusp Alfa Program Rollover Study	NCT05061823	Lung Cancer Cancer	Bintrafusp alfa	18 Years -	EMD Serono

Spots Global Cancer Trial Database for programmed death ligand 1