Study on New Treatment Combinations for Non-Small Cell Lung Cancer (NSCLC)
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07098338
This clinical trial is exploring new combinations of treatments for patients with advanced or spreading non-small cell lung cancer (NSCLC). The study is being conducted at around 80 centers in 10 countries and includes several sub-studies to test the safety and effectiveness of these treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to test new combinations of treatments for people with advanced or metastatic non-small cell lung cancer (NSCLC). The study is divided into several sub-studies, each focusing on different treatment combinations to see how safe they are and how well they work against the cancer. The trial is taking place in about 80 locations worldwide, across 10 countries.
Description
This study includes three sub-studies, each targeting a specific group of patients with NSCLC:
- Sub-study 1 will test the combination of rilvegostomig with or without ramucirumab in patients with NSCLC who have certain genetic changes that cannot be targeted with existing treatments and have a PD-L1 level of 50% or higher.
- Sub-study 2 will test the combination of rilvegostomig and ramucirumab in patients with NSCLC who have similar genetic changes but a PD-L1 level between 1% and 49%.
- Sub-study 3 will test the combination of Dato-DXd and ramucirumab, with or without rilvegostomig, in patients who have already received one line of treatment for NSCLC with these genetic changes.
Each sub-study may have two parts:
- Part A: Initial testing to ensure the treatment is safe.
- Part B: Further testing to see how well the treatment works in a larger group of patients.
Eligibility Criteria
Inclusion Criteria for All Sub-studies:
- Participant must be ≥ 18 years of age at the time of signing the ICF
- WHO/ECOG performance status of 0 or 1
- At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
- Adequate bone marrow and organ function
- Life expectancy ≥ 12 weeks
- Provision of acceptable tumour tissue
Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:
- Histologically or cytologically documented advanced or metastatic NSCLC
- PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
- Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)
Specific Inclusion Criteria for Sub-Study 3:
- Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
- Documented positive AGA and had progressed on prior targeted therapy
Exclusion Criteria for All Sub-studies:
- As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
- Active or prior documented autoimmune or inflammatory disorders
- Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
- Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
- Unstable brain metastases
- History of another primary malignancy.
- Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
- Uncontrolled or significant cardiac disease
- Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
- Prior exposure to immune-mediated therapy
- History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
- Any concurrent anti-cancer treatment.
- Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 90404 | Santa Monica | California |
| Research Site | 95403 | Santa Rosa | California |
| Research Site | 30318 | Atlanta | Georgia |
| Research Site | 21231 | Baltimore | Maryland |
| Research Site | 77090 | Houston | Texas |
| Research Site | 22031 | Fairfax | Virginia |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.