Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.

Recruiting now · Phase 4

Conditions studied: Non-small Cell Lung Cancer

In brief

This study is designed as a multi-cohort trial based on various patient biomarkers study with the potential to include new study treatment in the future. EGFR-sensitive mutation-positive patients with distant recurrence after adjuvant osimertinib treatment for EGFRm resectable SIB-IIIA NSCLC and scheduled to receive osimertinib plus chemotherapy will be enrolled in cohort 1. In this cohort, approximately 100 patients will be recruited from 25 sites in China. The enrolment period is planned to be approximately 16 months.

Key facts

Study ID: NCT07279935
Run by: AstraZeneca
People needed: 100
Starts: 2026-05-26
Expected to finish: 2030-05-18
Last updated by the study team: 2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients with only local/regional recurrence.
Spinal cord compression and symptomatic brain metastases.
Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
Adjuvant osimertinib therapy was discontinued due to the occurrence of severe adverse events.
Prior with other adjuvant EGFR-TKIs (excluding osimertinib).
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.
History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
Contraindication for pemetrexed and cisplatin/carboplatin according to local approved label.

Where it is running

Research Site — Nanjing, China (enrolling)
Research Site — Ningbo, China (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Jinan, China (enrolling)
Research Site — Fuzhou, China (enrolling)
Research Site — Shenyang, China (enrolling)
Research Site — Tianjin, China (enrolling)
Research Site — Nanchang, China (enrolling)
Research Site — Hangzhou, China (enrolling)
Research Site — Xi'an, China (enrolling)
Research Site — Fuzhou, China (enrolling)
Research Site — Zhengzhou, China (enrolling)
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shenyang, China
Research Site — Wuhan, China
Research Site — Wuhan, China
Research Site — Xi'an, China
Research Site — Kunming, China
Research Site — Beijing, China
Research Site — Chengdu, China
Research Site — Chongqing, China
Research Site — Guangzhou, China

Full record on ClinicalTrials.gov

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