Recruiting
Phase 2

Combination Treatment

Sponsor:

AstraZeneca

Code:

NCT07098338

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rilvegostomig

Ramucirumab

Dato-DXd

Study Details

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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT07098338

Start date

Aug 7, 2025

Status verified date

Jun, 2026

Completion date

Apr 6, 2029

Anticipated

Primary completion date

Apr 6, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

278 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%

Participants will receive rilvegostomig ± ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion

experimental: Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%

Participants will receive rilvegostomig + ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion

experimental: Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC

Participants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion

Interventions

Rilvegostomig

Rilvegostomig will be administered as IV infusion.

Ramucirumab

Ramucirumab will be administered as IV infusion.

Dato-DXd

Dato-DXd will be administered as IV infusion.

Primary outcome measure

  • Number of participants with adverse events (AE) and serious adverse events (SAE) [ Time Frame: Through study completion, an average of 3 years ]
  • Objective response rate (ORR) [ Time Frame: Through study completion, an average of 3 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Santa Monica, California, United States, 90404

Research Site

Recruiting

Atlanta, Georgia, United States, 30318

Research Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

AstraZeneca

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Non-Small Cell Lung Cancer(NSCLC)
  • Antibody-Drug Conjugates (ADCs)
  • T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT)
  • Programmed death-ligand 1 (PD-L1)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-01.