A Phase II, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
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Study 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.
- * 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
- Subjects with histologically or cytologically confirmed metastatic or locally advanced NSCLC (histological type adenocarcinoma) and who are not suitable for radical surgery or radiation therapy.
- Subjects must have experienced radiographic disease progression during or after their most recent treatment regimen.
- Subjects may or may not carry currently targetable driver gene variants.
- Subjects had measurable lesions at baseline that met RECIST version 1.1 criteria.
- Subjects with an ECOG PS score of 0 or 1 within the first 7 days of Day 1 of Cycle 1
- (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.
- The subject's NSCLC was histologically non-adenocarcinoma.
- Subjects must have a history of or current malignancy other than the enroll diagnosis prior to the first dose of the planned trial treatment, or evidence of any residual disease resulting from a previously diagnosed malignancy. Malignancies with negligible risk of metastasis or death (e.g., 5-year OS ≥ 90%) are excluded, including but not limited to adequately treated stage 1B or lower cervical cancer, basal cell or squamous cell skin cancer in situ, bladder cancer in situ, ductal carcinoma in situ, or any prior malignancy that has been cured for ≥ 3 years.
- Subjects with newly discovered or known unstable (e.g., progressive brain metastases) or symptomatic central nervous system (CNS) metastases or a history of carcinomatous meningitis (also known as leptomeningeal disease). Subjects with a history of spinal cord compression (caused by disease). Subjects who have previously received targeted CNS therapy for brain metastases (e.g., radiation therapy and/or surgery) are eligible to participate in the study if repeat imaging studies show that the lesions are radiographically stable (i.e., no evidence of progression) for at least 28 days.
Clinical Study Information for Healthcare Providers
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