*Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel in NSCLC
Research type
Research Study
Full title
A Randomised, Open-Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants with Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti PD (L)1 Therapy and Chemotherapy (COSTAR LUNG)
IRAS ID
288367
Contact name
Raffaele Califano
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd.
Eudract number
2020-003433-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 9 months, 14 days
Research summary
Cobolimab and dostarlimab are investigational drugs which are types of antibodies being developed by GSK to treat cancer. In this study we are aiming to treat Non-Small Cell Lung Cancer (NSCLC), the most common type of lung cancer.
Both cobolimab and dostarlimab help the immune system find and fight cancer cells.
Docetaxel is a type of chemotherapy drug currently used as standard of care.
The purpose of this study is to assess the effectiveness and safety of three different combinations of treatment, in participants with advanced NSCLC whose cancer has returned or worsened despite prior immunotherapy and chemotherapy.
The participants will be randomly allocated to 1 of the following treatment groups (Ratio of 2:2:1; Arm A: Arm B: Arm C). The participant and study doctors will know which treatment they are receiving.
- Arm A (cobolimab + dostarlimab + docetaxel).
- Arm B (dostarlimab + docetaxel),
- Arm C (docetaxel alone).The study will determine whether the combination treatment arms extend survival compared to docetaxel alone.
A participant’s time on study will include Screening (28 days), Treatment period; enrolled participants may continue study treatment until disease progression, unacceptable toxicity, participant withdrawal, investigator’s decision, or death.
Once criteria for discontinuation of treatment is reached the participants will enter a safety follow up period that will last for up to 90 days after the last dose.
Survival follow up will continue every 90 days until death, withdrawal of consent, loss to follow-up, or the end of study data collection.
This study will include up to 750 participants, randomly assigned to study treatment with 20 participants recruited from UK hospitals.
Tests undertaken will include but are not limited to blood tests, imaging (CT /MRI) Scans, vital signs, medical history review and questionnaires. The drugs will be given as infusions into the blood.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0297
Date of REC Opinion
4 Mar 2021
REC opinion
Further Information Favourable Opinion