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Taking people in TaiwanPhase 2

Tests new drug combinations in advanced non-small cell lung cancer

Tests new drug combinations in adults with advanced non-small cell lung cancer.

Key facts

Who runs it
AstraZeneca
Where
Liuying, Taichung, Tainan, Taipei, and Taoyuan, TaiwanSee the 5 sitesAlso in 11 other countries, 60 sites
Registry title
A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
Status
Recruiting
Phase
Phase 2
People taking part
278 people, planned
Started
7 Aug 2025
Expected to end
6 Apr 2029
Type of study
Interventional, 3 groups
Treatments tested
  • Rilvegostomig
  • Ramucirumab
  • Dato-DXd
Record updated
15 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). It tests new drug combinations in separate sub-studies.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Advanced or metastatic NSCLC, confirmed by tissue or cell tests. Sub-study 3 is for non-squamous NSCLC only. At least 1 tumour lesion that can be measured by RECIST 1.1 is needed.
Earlier treatment
Sub-studies 1 and 2: no earlier chemotherapy, chemoradiation or immunotherapy for advanced NSCLC. Sub-study 3: the cancer got worse on earlier targeted therapy. No earlier immune-mediated therapy.
Biomarker or test result
Sub-studies 1 and 2: PD-L1 TC at least 1% (at least 50% for sub-study 1, 1-49% for sub-study 2), and no sensitizing EGFR mutations, ALK rearrangements or other known actionable gene changes. Sub-study 3: a documented positive actionable gene change (AGA).

Main reasons for not taking part

  • Active or past autoimmune or inflammatory disorders
  • Unstable brain metastases
  • History of another primary cancer
  • Active infection, including TB, HIV, HBV or HCV
  • Uncontrolled or significant heart disease

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2
  • Prior exposure to immune-mediated therapy
  • Any concurrent anti-cancer treatment
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention
  • 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
  • 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
  • History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
  • 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

Where in Taiwan

Also in 11 other countries, 60 sites

  • LiuyingHospital not named in the registryTaking people
  • TaichungHospital not named in the registryTaking people
  • TainanHospital not named in the registryTaking people
  • TaipeiHospital not named in the registryTaking people
  • TaoyuanHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%Treatment being tested

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

    Treatment: Rilvegostomig and Ramucirumab

  • Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%Treatment being tested

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

    Treatment: Rilvegostomig and Ramucirumab

  • Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLCTreatment being tested

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

    Treatment: Rilvegostomig, Ramucirumab, and Dato-DXd

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)
Plain-language title
Tests new drug combinations in advanced non-small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 October 2026