Phase 2 Open‑Label Multicohort Study of Rinatabart Sesutecan Monotherapy in Patients with Locally Advanced or Metastatic Non‑Small Cell Lung Cancer

The primary objective is to assess the anti‑tumor activity of Rinatabart Sesutecan monotherapy in participants with Non‑Small Cell Lung Cancer, reflecting its potential to induce tumor regression.

• Evaluate additional measures of clinical efficacy, including antitumor activity and durability of response.
• Characterize the pharmacokinetics of Rinatabart Sesutecan following intravenous infusion.
• Determine the immunogenic potential of the agent.
• Assess the safety and tolerability profile of the monotherapy.

The trial enrolled 93 participants diagnosed with Non‑Small Cell Lung Cancer that was locally advanced or metastatic. Both male and female adults were included, encompassing the full adult age spectrum defined by the protocol. All subjects had a confirmed histological or cytological diagnosis of metastatic or unresectable locally advanced disease, demonstrated radiologic progression after prior therapy, and possessed measurable disease per RECIST v1.1. Eligibility required an Eastern Cooperative Oncology Group performance status of 0 or 1 within seven days before the first treatment cycle. The population comprised patients, including vulnerable individuals, who met these disease‑specific criteria; no additional lifestyle restrictions such as diet or physical activity were stipulated in the protocol.

This Phase 2, open‑label, multicohort study evaluates the anti‑tumor activity of Rinatabart Sesutecan monotherapy in participants with histologically confirmed non‑small cell lung cancer that is locally advanced or metastatic and not amenable to curative surgery or radiotherapy. Eligible individuals must exhibit disease progression on prior therapy, have measurable disease per RECIST v1.1, and an ECOG performance status of 0–1 within 7 days before Cycle 1 Day 1. The trial follows a single‑arm design without randomization or masking; treatment consists of intravenous infusion of Rinatabart Sesutecan administered every 21 days until documented disease progression, unacceptable toxicity, withdrawal, or study completion. The schedule includes a screening visit for eligibility assessments, a baseline visit (Cycle 1 Day 1) to initiate therapy, subsequent treatment cycles with safety labs and pharmacokinetic sampling, radiologic tumor assessments every 6–8 weeks, and an end‑of‑study visit after treatment discontinuation. Participants are expected to remain in the study for up to 4 years to allow evaluation of primary and secondary endpoints, including objective response rate, duration of response, disease‑control rate, progression‑free and overall survival, and safety parameters. Early termination may occur if the participant experiences grade ≥ 3 treatment‑emergent adverse events, rapid clinical deterioration, or withdrawal of consent.

The investigational agent, Rinatabart Sesutecan, is supplied as a solution for infusion intended for intravenous administration. The prescribed dose is 0 mg/m², delivered by intravenous infusion according to the study‑specific dosing schedule; administration is performed in the clinic under direct supervision. Dosing frequency and cycle length are defined in the protocol, and each infusion is recorded in the source documentation. Compliance with the infusion schedule is monitored by tracking administration dates, infusion start and end times, and any dose modifications documented by the study staff.

The study also incorporates an auxiliary product, PEGFILGRASTIM, provided in the pharmaceutical form identified as PHF00231MIG for subcutaneous use. The administered dose is 0 mg, given by subcutaneous injection according to the protocol‑defined schedule. Injection timing and site are documented, and adherence to the injection schedule is verified through study logs and participant visit records.

Efficacy will be evaluated primarily by the Objective Response Rate (ORR) determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator, with follow‑up conducted over an approximate three‑year period.

Key secondary efficacy measures include Duration of Response (DOR), Disease Control Rate (DCR), Progression‑free Survival (PFS), and Overall Survival (OS). These endpoints will be assessed by the same RECIST‑based imaging protocol and are planned for evaluation throughout an estimated four‑year observation window.

Radiologic assessments will be performed at baseline and at predefined intervals throughout the study, with imaging reviewed by the investigator to classify tumor responses per RECIST criteria. Data will be collected systematically, entered into a central database, and analyzed using standard statistical methods appropriate for time‑to‑event and proportion outcomes.