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

NCT07279935 | Recruiting Phase 4

• 1 other identifier: D5164L00004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 33

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Non-Small-Cell Lung; osimertinib

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of osimertinib + chemotherapy by evaluation of PFS in patients who had distant recurrence after adjuvant osimertinib.

  PFS is defined as the time from initiation of osimertinib combined with chemotherapy until progression per RECIST 1.1 as assessed by the investigator at local site, or death due to any cause. The analysis will include all patients who successfully enrolled in the study, satisfied all inclusion/exclusion criteria and have taken at least one dose of osimertinib plus chemotherapy. All events will be included, regardless of whether the patient withdraws from therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression. However, if the patient progresses or dies immediately after two or more consecutive missed visits, the patient will be censored at the time of the latest evaluable assessment prior to the two missed visits. The primary measure of interest is the median PFS.

  Approximately 52 months

Secondary Outcomes (6)

• ORR

  Approximately 52 months

• TTD

  Approximately 52 months

• depth of response

  Approximately 52 months

• DCR

  Approximately 52 months

• DoR

  Approximately 52 months

Other Outcomes (1)

• safety and tolerability

  Approximately 52 months

Study Arms (1)

Cohort1

EXPERIMENTAL

Treatment allocation according to molecular profile at recurrence. Cohort 1 consists of patients with Ex19del or L858R mutation.

Drug: Osimertinib+cisplatin or carboplatin + pemetrexed Edit

Interventions

Osimertinib+cisplatin or carboplatin + pemetrexed Edit DRUG

Cohort 1 treated with osimertinib 80 mg once daily (QD) in combination with platinum-based chemotherapy cisplatin \[75 mg/m2\] or carboplatin \[AUC5\]) plus pemetrexed (500 mg/m2) on Day 1 every 3 weeks (Q3W) for 4 cycles, followed by osimertinib QD and pemetrexed Q3W till RECIST 1.1-defined progression or until another discontinuation criterion is met.

Also known as: Cohort1

Cohort1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (33)

Research Site

Beijing, 100021, China

NOT YET RECRUITING

Research Site

Beijing, 100044, China

RECRUITING

Research Site

Beijing, 100142, China

NOT YET RECRUITING

Research Site

Chengdu, 610041, China

RECRUITING

Research Site

Chengdu, 610041, China

NOT YET RECRUITING

Research Site

Chongqing, 400016, China

NOT YET RECRUITING

Research Site

Fuzhou, 350001, China

RECRUITING

Research Site

Fuzhou, 350005, China

RECRUITING

Research Site

Guangzhou, 510080, China

NOT YET RECRUITING

Research Site

Guangzhou, 510100, China

WITHDRAWN

Research Site

Guangzhou, 510289, China

NOT YET RECRUITING

Research Site

Hangzhou, 310020, China

RECRUITING

Research Site

Hefei, 230022, China

NOT YET RECRUITING

Research Site

Hefei, 230031, China

WITHDRAWN

Research Site

Jinan, 250014, China

WITHDRAWN

Research Site

Jinan, 250014, China

RECRUITING

Research Site

Kunming, 650118, China

WITHDRAWN

Research Site

Nanchang, 330006, China

RECRUITING

Research Site

Nanchang, 330006, China

NOT YET RECRUITING

Research Site

Nanjing, 2100008, China

WITHDRAWN

Research Site

Nanjing, 210009, China

RECRUITING

Research Site

Ningbo, 315010, China

RECRUITING

Research Site

Shanghai, 200030, China

NOT YET RECRUITING

Research Site

Shanghai, 200120, China

WITHDRAWN

Research Site

Shanghai, 200433, China

WITHDRAWN

Research Site

Shenyang, 110004, China

NOT YET RECRUITING

Research Site

Shenyang, 110042, China

RECRUITING

Research Site

Tianjin, 300060, China

RECRUITING

Research Site

Wuhan, 430022, China

NOT YET RECRUITING

Research Site

Wuhan, 430030, China

NOT YET RECRUITING

Research Site

Xi'an, 710004, China

RECRUITING

Research Site

Xi'an, 710061, China

WITHDRAWN

Research Site

Zhengzhou, 450008, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Bronchial Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: May 26, 2026
• Primary Completion (Estimated): May 18, 2030
• Study Completion (Estimated): May 18, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CN (33)