A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rilvegostomig, Ramucirumab, Dato-DXd.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, China, France +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Detailed description
The master protocol will include 3 sub-studies, each focused on a specific disease population.
* Sub-study 1 will investigate rilvegostomig± ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 ≥50%. * Sub-study 2 will investigate rilvegostomig + ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 1-49%. * Sub-study 3 will investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+
Each sub-study may include 2 parts (unless stated in the individual sub study protocols): Part A: one or more Safety Run-in cohort(s), and Part B: one or more Dose Expansion cohort(s).
Interventions
- Drug Rilvegostomig
Rilvegostomig will be administered as IV infusion. - Drug Ramucirumab
Ramucirumab will be administered as IV infusion. - Drug Dato-DXd
Dato-DXd will be administered as IV infusion.
Primary outcome measures
- 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]
Secondary outcome measures (9)
- Best Overall Response(BOR) [Time frame: Through study completion, an average of 3 years]
- Change in Target Lesion Tumor Size [Time frame: Through study completion, an average of 3 years]
- Progression free survival (PFS) [Time frame: Through study completion, an average of 3 years]
- Disease Control Rate(DCR) at 12 Weeks [Time frame: From Day 1 pre-dose to 12 weeks]
- Duration Of Response (DoR) [Time frame: Through study completion, an average of 3 years]
- Overall Survival(OS) [Time frame: Through study completion, an average of 3 years]
- Serum concentration [Time frame: Through study completion, an average of 3 years]
- Maximum plasma drug concentration (Cmax) [Time frame: Through study completion, an average of 3 years]
- Immunogenicity of study interventions in participants receiving treatment [Time frame: Through study completion, an average of 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 19 centers
- Research Site — Changsha
- Research Site — Chengdu
- Research Site — Deyang
- Research Site — Dongguan
- Research Site — Fuzhou
- Research Site — Guangzhou
- Research Site — Guangzhou
- Research Site — Hangzhou
- … and 11 more centers
Japan · 11 centers
- Research Site — Bunkyō City
- Research Site — Fukuyama-shi
- Research Site — Kobe
- Research Site — Kurume-shi
- Research Site — Kyoto
- Research Site — Kyoto
- Research Site — Osaka
- Research Site — Sakaishi
- … and 3 more centers
South Korea · 9 centers
- Research Site — Cheongju-si
- Research Site — Namdong-gu
- Research Site — Seongnam-si
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Suwon
- … and 1 more center
Taiwan · 9 centers
- Research Site — Liuying
- Research Site — Taichung
- Research Site — Taichung
- Research Site — Tainan
- Research Site — Tainan
- Research Site — Taipei
- Research Site — Taipei
- Research Site — Taipei
- … and 1 more center
Italy · 8 centers
- Research Site — Aviano
- Research Site — Catania
- Research Site — Meldola
- Research Site — Milan
- Research Site — Milan
- Research Site — Orbassano
- Research Site — Roma
- Research Site — Rozzano
United States · 6 centers
- Research Site — Santa Monica
- Research Site — Santa Rosa
- Research Site — Atlanta
- Research Site — Baltimore
- Research Site — Houston
- Research Site — Fairfax
Spain · 6 centers
- Research Site — A Coruña
- Research Site — Madrid
- Research Site — Manresa
- Research Site — Málaga
- Research Site — Santander
- Research Site — Valencia
France · 5 centers
- Research Site — Avignon
- Research Site — Paris
- Research Site — Rennes
- Research Site — Saint-Herblain
- Research Site — Suresnes
Thailand · 4 centers
- Research Site — Bangkok
- … and 3 more centers
Australia · 3 centers
- Research Site — Heidelberg
- Research Site — Nedlands
- Research Site — Woodville
Singapore · 2 centers
- Research Site — Singapore
- Research Site — Singapore
Canada · 1 center
- Research Site — Toronto
Identifiers
NCT: NCT07098338 · D6187C00001