Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
18 Years and older, Male and Female
GCT1184-05 (primary)
NCI-2026-02378
2025
2025-522107-18-00
CTR20260819
jRCT2041250176
Summary
This Phase 2 study will be conducted in different countries around the world with up to
about 240 participants.
The purpose of this study is to evaluate how well Rina-S works against lung cancer.
The treatment in this study is Rina-S monotherapy (by itself). All participants will
receive active drug; no one will be given placebo.
The treatment duration will be different for every participant, but an average of 12
months is expected. Participants will be asked to attend 1 to 5 visits at the study
clinic for each cycle (duration of cycle is 3 weeks). If a participant's cancer stays the
same or gets better, and there are not any serious problems, participants can keep
getting study treatment for as long as the study is open.
Participation in the study will require visits to the study site(s). During site visits,
there will be various tests (such as blood draws) and procedures (such as recording of
heart activity, imaging/X-rays) to monitor whether the study treatment is safe and
effective.
Objectives
This is a Phase 2, open-label, multicenter, multi-cohort trial to evaluate the safety,
efficacy, pharmacokinetics (PK), and pharmacodynamics of Rina-S as monotherapy in
participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), with
or without select genomic aberrations.
Eligibility
- Key Inclusion Criteria:
- Participant has histologically or cytologically confirmed metastatic or locally
advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or
radiotherapy.
- Participant must have radiological disease progression while on or after receiving
the most recent regimen.
- Participants either may have actionable genetic alterations (AGAs) or no AGAs.
- Participant has measurable disease according to RECIST v1.1.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
score of 0 or 1 within 7 days of Cycle 1 Day 1.
Key Exclusion Criteria (all study cohorts):
- Participant has NSCLC with histology other than adenocarcinoma
- Participant has a past or current malignancy other than the inclusion diagnosis
before the planned first dose of trial treatment, or any evidence of residual
disease from a previously diagnosed malignancy. Exceptions are malignancies with a
negligible risk of metastasis or death (eg, 5-year OS = 90%), including, but not
limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal
cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in
situ, or any past malignancy considered cured for = 3 years.
- Participants with newly identified or known unstable (eg, progressing brain
metastases) or symptomatic central nervous system (CNS) metastases or history of
carcinomatous meningitis (also known as leptomeningeal disease). Participants with
history of spinal cord compression (from disease). Participants with previous
CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may
participate provided lesion(s) are radiologically stable (ie, without evidence of
progression) for at least 28 days by repeat imaging.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Treatment Sites in Georgia
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