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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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).
Show all 10Show fewer
  • 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

1-877-240-9479

information.center@astrazeneca.com

32 sites in 1 country

China32 sites, 24 recruiting

  • Research Site

    Beijing, 100021

    Not yet recruiting

  • Research Site

    Beijing, 100044

    Recruiting

  • Research Site

    Beijing, 100142

    Recruiting

  • Research Site

    Chengdu, 610031

    Not yet 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

    Recruiting

  • Research Site

    Guangzhou, 510100

    Withdrawn

  • Research Site

    Guangzhou, 510289

    Recruiting

  • Research Site

    Hangzhou, 310016

    Recruiting

  • Research Site

    Hefei, 230022

    Recruiting

  • Research Site

    Hefei, 230031

    Withdrawn

  • Research Site

    Jinan, 250014

    Withdrawn

  • Research Site

    Jinan, 250014

    Recruiting

  • Research Site

    Kunming, 650118

    Withdrawn

  • Research Site

    Nanchang, 330006

    Recruiting

  • Research Site

    Nanjing, 2100008

    Withdrawn

  • Research Site

    Nanjing, 210009

    Recruiting

  • Research Site

    Ningbo, 315010

    Recruiting

  • Research Site

    Shanghai, 200030

    Recruiting

  • Research Site

    Shanghai, 200120

    Withdrawn

  • Research Site

    Shanghai, 200433

    Withdrawn

  • 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

    Recruiting

  • Research Site

    Xi'an, 710061

    Withdrawn

  • Research Site

    Zhengzhou, 450008

    Recruiting

Other trials in China

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.

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 groups in NCT07279935
Study groupRoleWhat they receive
Cohort1ExperimentalTreatment 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.

  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.

    Measured: Approximately 52 months

Secondary outcomes (6)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted12 Dec 2025
  2. Study start26 May 2026
  3. Primary completion18 May 2030 (estimated)
  4. Study completion18 May 2030 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the efficacy of osimertinib + chemotherapy by evaluation of PFS in patients who had distant recurrence after adjuvant osimertinib. (time frame: Approximately 52 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07279935.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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