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

Recruiting · NCT07098338 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 5 US states.

Research Site - Santa Monica, California, United States
Research Site - Santa Rosa, California, United States
Research Site - Atlanta, Georgia, United States
Research Site - Baltimore, Maryland, United States
Research Site - Houston, Texas, United States
Research Site - Fairfax, Virginia, United States
Research Site - A Coruña, Spain
Research Site - Aviano, Italy
Research Site - Avignon, France
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Banphaeo, Thailand
Research Site - Bunkyō City, Japan
Research Site - Catania, Italy
Research Site - Changsha, China
Research Site - Chengdu, China
Research Site - Cheongju-si, South Korea
Research Site - Deyang, China
Research Site - Dongguan, China
Research Site - Fukuyama-shi, Japan
Research Site - Fuzhou, China
Research Site - Guangzhou, China
Research Site - Guangzhou, China
Research Site - Hangzhou, China
Research Site - Hefei, China
Research Site - Heidelberg, Australia
Research Site - Kobe, Japan
Research Site - Kurume-shi, Japan
Research Site - Kyoto, Japan
Research Site - Kyoto, Japan
Research Site - Linyi, China
Research Site - Liuying, Taiwan
Research Site - Madrid, Spain
Research Site - Manresa, Spain
Research Site - Meldola, Italy
Research Site - Mianyang, China
Research Site - Milan, Italy
Research Site - Milan, Italy
Research Site - Málaga, Spain
Research Site - Namdong-gu, South Korea
Research Site - Nanchang, China
Research Site - Nanchang, China
Research Site - Nedlands, Australia
Research Site - Orbassano, Italy
Research Site - Osaka, Japan
Research Site - Paris, France
Research Site - Rennes, France
Research Site - Roma, Italy
Research Site - Rozzano, Italy
Research Site - Saint-Herblain, France
Research Site - Sakaishi, Japan
Research Site - Santander, Spain
Research Site - Seongnam-si, South Korea
Research Site - Seoul, South Korea
Research Site - Seoul, South Korea
Research Site - Seoul, South Korea
Research Site - Seoul, South Korea
Research Site - Shantou, China
Research Site - Shenyang, China

Showing 60 of 83 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →