Osimertinib plus chemotherapy for EGFR-mutated lung cancer that returned after earlier osimertinib
Tests osimertinib with chemotherapy in non-small cell lung cancer that came back.
Plain-language title generated from the registry record
Registry title: Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.
Key facts
- Where
- Beijing, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Hefei, Jinan, Kunming, Nanchang, Nanjing, Ningbo, Shanghai, Shenyang, Tianjin, Wuhan, Xi'an, and Zhengzhou, ChinaSee the 18 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose EGFR-mutated lung cancer came back in other parts of the body after surgery and adjuvant osimertinib. They would get osimertinib plus chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Non-squamous non-small cell lung cancer that was fully removed by surgery at stage IB to IIIA. It has come back as new distant cancer (stage IVA or IVB). Stable or symptom-free brain spread is allowed.
- Earlier treatment
- Must have had adjuvant osimertinib after surgery. The cancer came back at least 6 months after stopping it and while off treatment. No cancer drug treatment since then. Local treatment such as surgery or radiotherapy is allowed.
- Biomarker or test result
- EGFR mutation (Exon 19del or Exon 21 L858R), reconfirmed by NGS on a blood plasma sample (and tissue if available).
Main reasons for not taking part
- Cancer came back only locally or in nearby areas
- Spinal cord compression or brain metastases with symptoms
- History of ILD or pneumonitis (lung inflammation)
- Adjuvant osimertinib stopped because of severe side effects
- Earlier adjuvant treatment with another EGFR-TKI
Read by machine on 12 November 2026.
Where in China
- BeijingHospital not named in the registryNot yet recruiting
- ChengduHospital not named in the registryNot yet recruiting
- ChongqingHospital not named in the registryTaking people
- FuzhouHospital not named in the registryTaking people
- GuangzhouHospital not named in the registryTaking people
- HangzhouHospital not named in the registryTaking people
- HefeiHospital not named in the registryTaking people
- JinanHospital not named in the registryNo longer taking part
- KunmingHospital not named in the registryNo longer taking part
- NanchangHospital not named in the registryTaking people
- NanjingHospital not named in the registryNo longer taking part
- NingboHospital not named in the registryTaking people
- ShanghaiHospital not named in the registryTaking people
- ShenyangHospital not named in the registryTaking people
- TianjinHospital not named in the registryTaking people
- WuhanHospital not named in the registryTaking people
- Xi'anHospital not named in the registryTaking people
- ZhengzhouHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07279935
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
Biomarker-Directed Treatment in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC: A Prospective, Multi-cohort, Interventional Study (REVIVE)
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.
Inclusion: Prior complete surgical resection (R0) and adjuvant osimertinib in EGFRm resectable SIB-IIIA NSCLC (AJCC 7th edition); Off-treatment recurrence (including completed 3 years adjuvant osimertinib \& discontinued adjuvant osimertinib before 3 years due to non-recurrence reason); Newly diagnosed distant recurrent NSCLC (IVA or IVB) (per Version 9 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology); ≥6 months interval between recurrence and completion or discontinuation of adjuvant osimertinib; Histologically/cytologically confirmed nonsquamous NSCLC (Investigators confirmed recurrence of primary lesion allowed if biopsy not available); No prior systemic anti-cancer therapy after adjuvant therapy, but can receive local therapy (including surgery, radiotherapy, etc. per investigator choice); Patients with asymptomatic or stable CNS metastases allowed; Male or female, at least 18 years of age. Type of patient and disease characteristics; EGFR mutation (Exon 19del/Exon 21 L858R)-reconfirmed for study entry (mandatory undergo NGS by plasma, and tissue if applicable); Life expectancy >12 weeks at Day 1.
Exclusion: Adjuvant osimertinib therapy was discontinued due to the occurrence of severe adverse events; 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; Past medical history of ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening; History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib; Prior with other adjuvant EGFR-TKIs (excluding osimertinib); Patients with only local/regional recurrence; Spinal cord compression and symptomatic brain metastases; Contraindication for pemetrexed and cisplatin/carboplatin according to local approved label.