Multiple Treatments for Non-Small Cell Lung Cancer

(ALTAIR Trial)

Recruiting at 66 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: Immunosuppressants, Anti-PD-1, Anti-PD-L1, CTLA-4

Disqualifiers: EGFR mutations, Uncontrolled hypertension, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

143 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.

Eligibility Criteria

This trial is for individuals with advanced non-small cell lung cancer (NSCLC). Participants should be adults who can provide informed consent and are eligible to receive chemotherapy. Specific criteria may vary, so it's important to consult the study team for details.

Inclusion Criteria

Minimum life expectancy of 12 weeks in the opinion of the investigator

Contraceptive use by male or female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Minimum body weight of 30 Kg

Exclusion Criteria

I don't have severe side effects from previous cancer treatments or serious brain/spinal issues.

My cancer has a specific genetic change that can be treated with targeted therapy.

I do not have any severe illnesses like uncontrolled high blood pressure, active infections, or serious chronic conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Sub-study 1 Part A

Safety run-in to evaluate 2 or more dose levels to identify the recommended Phase 2 dose (RP2D) of AB248 in combination with rilvegostomig

Approximately 46 months

Treatment - Sub-study 1 Part B

Dose expansion where participants receive AB248 in combination with rilvegostomig based on the RP2D

Approximately 46 months

Treatment - Sub-study 2 Part B

Participants with non-squamous NSCLC receive SoC cisplatin or carboplatin, pemetrexed plus rilvegostomig, followed by pemetrexed plus rilvegostomig. Participants with squamous NSCLC receive SoC carboplatin plus paclitaxel or nab-paclitaxel plus rilvegostomig, followed by rilvegostomig

Approximately 46 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12-24 months

Treatment Details

Interventions

• AB248
• Cisplatin
• Nab-paclitaxel
• Pemetrexed
• Rilvegostomig

Trial Overview The trial is testing various treatments including new drug combinations and standard therapies like Nab-paclitaxel, Pemetrexed, Paclitaxel, Cisplatin, Rilvegostomig, AB248, and Carboplatin to see which works best for metastatic NSCLC.

Participant Groups

Group I: Sub study 2 Part B: Dose expansion Experimental Treatment 6 Interventions

Participants with non-squamous NSCLC will receive the combination of SoC cisplatin or carboplatin, pemetrexed plus rilvegostomig, followed by pemetrexed plus rilvegostomig and participants with squamous NSCLC will receive the combination of SoC carboplatin plus paclitaxel or nab-paclitaxel plus rilvegostomig, followed by rilvegostomig until RECIST 1.1-defined radiological progression as assessed by the investigator, unacceptable toxicity, or until any other intervention discontinuation criterion is met.

Group II: Sub study 1 Part B: Dose expansion Experimental Treatment 2 Interventions

Participants with squamous and non-squamous NSCLC (programmed death-ligand 1 \[PD-L1\] ≥ 50% and PD-L1 1-49%) will receive AB248 in combination with rilvegostomig based on the RP2D determined in Part A.

Group III: Sub study 1 Part A: Safety run-in Experimental Treatment 2 Interventions

Participants will receive AB248 in combination with rilvegostomig to identify the RP2D to futher evaluate the combination in Part B.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology