A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)

About

Brief Summary

This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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.

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Study Stats

Protocol No.

25-1538