Table 1. Key inclusion criteria.

Inclusion criteria

(I) Age of ≥18 years at the time of informed consent

(II) Provision of written informed consent

(III) Histologically confirmed stage III with no indication for curative surgery, radiotherapy, stage IV, or recurrent NSCLC

(IV) No sensitizing epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements in patients with non-squamous carcinoma

(V) No or unknown ROS-1 rearrangement, BRAF (V600E) gene mutation, MET exon 14 skipping mutation, RET rearrangement, or NTRK rearrangement

(VI) Disease progression during or after the most recent treatment and history of treatment

(VII) Patients who received the following treatments

• Platinum doublet chemotherapy

• Immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab, atezolizumab, nivolumab, and ipilimumab)

• Chemotherapy (e.g., pemetrexed, docetaxel, nab-paclitaxel, S-1)

(VIII) Measurable lesions based on RECIST Ver.1.1

(IX) Eastern Cooperative Oncology Group performance status of 0–1

(X) Estimated life expectancy of >3 months

(XI) Adequate organ function within 7 days prior to registration

NSCLC, non-small cell lung cancer; RECIST, Response Evaluation Criteria in Solid Tumors.