Osimertinib Plus Chemotherapy After Distant Recurrence in EGFRm NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4, multi-cohort interventional trial enrolling EGFR-mutant NSCLC patients with distant recurrence after adjuvant osimertinib. Cohort 1 will include about 100 patients from 25 sites in China who will receive osimertinib in combination with platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed). Eligible patients have completed adjuvant osimertinib, experienced recurrence more than 6 months after stopping adjuvant therapy, and have nonsquamous histology. The study aims to explore safety and potential efficacy of the combination as a real-world post-recurrence strategy. Enrollment is planned to last around 16 months.

Why it matters

Who can join: the full rules

Inclusion Criteria for pre-screening:

1. Prior complete surgical resection (R0) and adjuvant osimertinib in EGFRm resectable SIB-IIIA NSCLC (AJCC 7th edition).
2. Off-treatment recurrence (including completed 3 years adjuvant osimertinib \& discontinued adjuvant osimertinib before 3 years due to non-recurrence reason).
3. 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).
4. ≥6 months interval between recurrence and completion or discontinuation of adjuvant osimertinib.
5. Histologically/cytologically confirmed nonsquamous NSCLC (Investigators confirmed recurrence of primary lesion allowed if biopsy not available)
6. No prior systemic anti-cancer therapy after adjuvant therapy, but can receive local therapy (including surgery, radiotherapy, etc. per investigator choice).
7. Patients with asymptomatic or stable CNS metastases allowed.

Inclusion Criteria for screening:

1. Male or female, at least 18 years of age. Type of patient and disease characteristics
2. EGFR mutation (Exon 19del/Exon 21 L858R)-reconfirmed for study entry (mandatory undergo NGS by plasma, and tissue if applicable).
3. Life expectancy \>12 weeks at Day 1.

Exclusion Criteria:

1. Patients with only local/regional recurrence.
2. Spinal cord compression and symptomatic brain metastases.
3. 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.
4. Adjuvant osimertinib therapy was discontinued due to the occurrence of severe adverse events.
5. Prior with other adjuvant EGFR-TKIs (excluding osimertinib).
6. 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.
7. History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
8. Contraindication for pemetrexed and cisplatin/carboplatin according to local approved label.

Where it's running

• Research Site
  Beijing, China Recruiting
• Research Site
  Beijing, China Recruiting
• Research Site
  Chengdu, China Recruiting
• Research Site
  Chongqing, China Recruiting
• Research Site
  Fuzhou, China Recruiting
• Research Site
  Fuzhou, China Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

• Izalontamab Brengitecan with Osimertinib in EGFR-mutant NSCLC: first-line versus standard options

  This study tests whether adding iza-bren to osimertinib can help people with newly diagnosed EGFR-mutant non-small cell lung cancer, compared with osimertinib alone or osimertinib plus platinum-based chemotherapy.

  Recruiting at 10 sites Phase 3 Bristol-Myers Squibb · Beverly Hills, California and 204 other locations · NCT07680790

• BL-B01D1 with Osimertinib before/around surgery for EGFR-mutant resectable NSCLC

  A Phase II/III trial tests if adding BL-B01D1 to osimertinib around surgery helps people with resectable EGFR-mutant non-small cell lung cancer.

  Recruiting at 2 sites Phase 2/3 Sichuan Baili Pharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality and 1 other locations · NCT07642024

• Barriers and facilitators to sticking with osimertinib after early-stage NSCLC

  This study asks how adults with early-stage NSCLC in China continue or stop adjuvant osimertinib, by talking with patients and doctors to understand what helps or hinders persistence.

  Recruiting AstraZeneca · Beijing · NCT07542210

• Ivonescimab with datopotamab deruxtecan or osimertinib for EGFR‑mutant non‑small cell lung cancer

  This trial will test whether combining ivonescimab with datopotamab deruxtecan or with osimertinib is safe and helps people with metastatic EGFR‑mutant non‑small cell lung cancer who have already received third‑generation EGFR inhibitors and chemotherapy.

  Recruiting at 7 sites Phase 1/2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07535437

• Boosting Osimertinib brain penetration with febuxostat in EGFR-mutated NSCLC

  This study tests whether adding febuxostat to osimertinib can increase osimertinib levels in the brain for patients with EGFR-mutated NSCLC who do not have CNS metastases.

  Recruiting Phase 2 Maastricht University Medical Center · Amsterdam and 1 other locations · NCT07485452

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.