Tests new drug combinations in advanced non-small cell lung cancer
Tests new drug combinations in adults with advanced non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
Key facts
- Where
- Heidelberg, Nedlands, and Woodville, AustraliaSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Where in Australia
- HeidelbergHeidelberg, AustraliaNot yet recruiting
- NedlandsNedlands, AustraliaNot yet recruiting
- WoodvilleWoodville, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07098338EU 2025-524843-11-00
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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.