Non-small Cell Lung CancerPhase 4REVIVENCT07279935
Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.
A Phase 4 study testing Osimertinib+cisplatin or carboplatin + pemetrexed Edit in people with Non-small Cell Lung Cancer, run by AstraZeneca at 32 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Osimertinib+cisplatin or carboplatin + pemetrexed Edit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 32 sitesChina
- Study dates
- 26 May 2026to 18 May 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- Patients with only local/regional recurrence.
- Spinal cord compression and symptomatic brain metastases.
- 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.
- 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.
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
32 sites in 1 country
China32 sites, 24 recruiting
- Not yet recruiting
Research Site
Beijing, 100021
- Recruiting
Research Site
Beijing, 100044
- Recruiting
Research Site
Beijing, 100142
- Not yet recruiting
Research Site
Chengdu, 610031
- Recruiting
Research Site
Chengdu, 610041
- Recruiting
Research Site
Chongqing, 400016
- Recruiting
Research Site
Fuzhou, 350001
- Recruiting
Research Site
Fuzhou, 350005
- Recruiting
Research Site
Guangzhou, 510080
- Withdrawn
Research Site
Guangzhou, 510100
- Recruiting
Research Site
Guangzhou, 510289
- Recruiting
Research Site
Hangzhou, 310016
- Recruiting
Research Site
Hefei, 230022
- Withdrawn
Research Site
Hefei, 230031
- Withdrawn
Research Site
Jinan, 250014
- Recruiting
Research Site
Jinan, 250014
- Withdrawn
Research Site
Kunming, 650118
- Recruiting
Research Site
Nanchang, 330006
- Withdrawn
Research Site
Nanjing, 2100008
- Recruiting
Research Site
Nanjing, 210009
- Recruiting
Research Site
Ningbo, 315010
- Recruiting
Research Site
Shanghai, 200030
- Withdrawn
Research Site
Shanghai, 200120
- Withdrawn
Research Site
Shanghai, 200433
- Recruiting
Research Site
Shenyang, 110004
- Recruiting
Research Site
Shenyang, 110042
- Recruiting
Research Site
Tianjin, 300060
- Recruiting
Research Site
Wuhan, 430022
- Recruiting
Research Site
Wuhan, 430030
- Recruiting
Research Site
Xi'an, 710004
- Withdrawn
Research Site
Xi'an, 710061
- Recruiting
Research Site
Zhengzhou, 450008
About this study
Official title: 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Osimertinib+cisplatin or carboplatin + pemetrexed Edit
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osimertinib+cisplatin or carboplatin + pemetrexed EditDrug
Also called Cohort1
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Experimental | Treatment allocation according to molecular profile at recurrence. Cohort 1 consists of patients with Ex19del or L858R mutation. Receives: Drug: Osimertinib+cisplatin or carboplatin + pemetrexed Edit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 52 months
Secondary outcomes (6)
ORR
ORR is defined as the proportion of patients who have a confirmed CR or confirmed PR as determined by the investigator at local site per RECIST 1.1.
The analysis will include all enrolled patients have taken at least one dose of osi plus chemotherapy. Data obtained from first dose up until progression, or the last evaluable assessment in the absence of progression will be included in the assessment of ORR, regardless of whether the patient withdraws from therapy. Patient who discontinues treatment without a response or progression, receive a subsequent therapy, and then respond will not be included as responder in the ORR.
Measured: Approximately 52 months
TTD
TTD is defined as time from first dose of osimertinib + chemotherapy until discontinuation of treatment for any reason, including disease progression, toxicity, and death. 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. Median TTD will be described.
Measured: Approximately 52 months
depth of response
Depth of response (ie, tumour shrinkage/change in tumour size) by investigator assessment at local site was defined as the relative change in the sum of the longest diameters of RECIST target lesions at the nadir in the absence of new lesions or progression of non-target lesions compared to baseline.
Measured: Approximately 52 months
DCR
DCR is defined as the percentage of patients who have a confirmed CR/PR or who have SD for at least 6 weeks minus 1 week per RECIST 1.1 as assessed by local site after date of first dose.
Measured: Approximately 52 months
DoR
DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause.
The primary measure of interest is the median DoR.
Measured: Approximately 52 months
OS
OS is defined as time from first dose of osimertinib and chemotherapy until the date of death due to any cause.
Landmark rate at 36 months of OS will be described.
Measured: Approximately 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start26 May 2026
- Primary completion18 May 2030 (estimated)
- Study completion18 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279935
- Sponsor's protocol ID
- D5164L00004
- Acronym
- REVIVE
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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