Multiple Treatments for Non-Small Cell Lung Cancer

(ALTAIR Trial)

Not yet recruiting at 89 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatment combinations for individuals with metastatic non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Researchers aim to determine if these new drug combinations, including both standard and experimental medicines such as AB248 and Rilvegostomig, are safe and effective. Participants must have Stage IV NSCLC, be able to provide a tumor sample, and possess a specific type of tumor marker called PD-L1. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive potentially groundbreaking therapies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on medications known to cause certain heart rhythm issues or are under chronic therapy with antiplatelet agents, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is currently examining the safety and tolerability of combining AB248 with rilvegostomig. Since this study is in its early stages, limited safety information is available for this specific combination.

For the combination of rilvegostomig with ramucirumab and chemotherapy, previous studies have explored similar treatments. These studies focus on patient responses and any side effects experienced. Because this study involves both new and standard treatments, early trials aim to determine safe dosage levels and monitor for side effects.

Both combinations are being tested in early-stage trials. The main goal is to ensure safety and find the right doses before later stages test treatment effectiveness. Reaching this phase suggests some initial confidence in safety from earlier lab or animal tests. However, more data is needed to fully understand its safety for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for non-small cell lung cancer (NSCLC) because they showcase innovative approaches that differ from the standard options like surgery, radiation, and chemotherapy with agents such as cisplatin and pemetrexed. The investigational treatment AB248 is combined with rilvegostomig and targets cancer cells through a novel mechanism that may enhance the body's immune response against tumors. Meanwhile, rilvegostomig, when paired with ramucirumab and chemotherapy, is being studied for its potential to improve outcomes by leveraging its unique ability to inhibit specific growth factors in cancer cells. These combinations aim to offer more effective and tailored options for patients with both squamous and non-squamous NSCLC.

What evidence suggests that this trial's treatments could be effective for metastatic NSCLC?

Research has shown that combining the drugs AB248 and rilvegostomig may help treat non-small cell lung cancer (NSCLC). This trial will evaluate the effectiveness of this combination in some participants. Patients who previously used rilvegostomig have generally tolerated it well and experienced positive early results. Other participants in this trial will receive a combination of rilvegostomig with ramucirumab and chemotherapy, which studies suggest could benefit those with advanced NSCLC. Both drug combinations aim to enhance treatment effectiveness, and researchers remain hopeful about their potential impact. These findings offer hope that these treatments might improve outcomes for people with advanced NSCLC. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Sub study 2 Part B: Dose expansion Experimental Treatment 7 Interventions

Participants will be randomised 1:1 into one of 2 treatment arms (rilvegostomig + chemotherapy + ramucirumab OR rilvegostomig + chemotherapy) in non-squamous histology cohorts and into a single arm (rilvegostomig + chemotherapy+ ramucirumab) in squamous histology cohorts.

Group II: Sub study 2 Part A: Safety run-in Experimental Treatment 7 Interventions

Participants with squamous and non-squamous NSCLC will receive combination therapy of rilvegostomig, ramucirumab, and platinum-based chemotherapy to assess the safety and tolerability of this regimen.

Group III: 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 IV: 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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06996782

A Platform Study in Non-Small Cell Lung Cancer (NSCLC)

Sub-study 1 will investigate the safety, tolerability, and anti-tumour activity of combination of rilvegostomig and AB248. Sub-study 2 will evaluate the safety, ...

2.

astrazenecaclinicaltrials.com

astrazenecaclinicaltrials.com/study/D702KC00001

A Platform Study in Non-Small Cell Lung Cancer (NSCLC)

Sub-study 1 will investigate the safety, tolerability, and anti-tumour activity of combination of rilvegostomig and AB248. Sub-study 2 will evaluate the safety, ...

3.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/asher-biotherapeutics-ab248-rilvegostomig-in-nsclc-phase-1b-2-study-announced/

Asher Biotherapeutics AB248 & Rilvegostomig in NSCLC

This combination therapy will be investigated as a first-line treatment for patients with advanced or metastatic non-small cell lung cancer ( ...

4.

synapse.patsnap.com

synapse.patsnap.com/article/asher-bio-announces-agreement-for-ab248-and-rilvegostomig-study-in-nsclc

Asher Bio Announces Agreement for AB248 and ...

Asher Bio is conducting a Phase 1a/1b clinical trial, AB248-101, to explore the safety, pharmacokinetics, pharmacodynamics, and anti-tumor ...

5.

lungcancerstoday.com

lungcancerstoday.com/post/rilvegostomig-appears-safe-effective-for-cpi-naive-metastatic-nsclc

Rilvegostomig Appears Safe and Effective for CPI-naïve ...

Rilvegostomig showed a favorable safety profile and encouraging preliminary efficacy in NSCLC.

6.

asherbio.com

asherbio.com/2025/01/07/asher-bio-announces-clinical-supply-agreement-to-enable-evaluation-of-etakafusp-alfa-ab248-in-combination-with-rilvegostomig-in-a-global-phase-1b-2-study-in-non-small-cell-lung-cancer-nsclc/

NEWS

Lung cancer has a 5-year relative survival rate of only 26.7% 2, representing a significant unmet need for additional treatment options for ...