A Phase 4 interventional study of Osimertinib+cisplatin or carboplatin + pemetrexed Edit in Non-small Cell Lung Cancer, sponsored by AstraZeneca. Recruiting at 32 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for pre-screening:
Inclusion Criteria for screening:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
This study also gives Osimertinib. No intervention listed here names it: that was found by reading the record.
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.
Time frame: Approximately 52 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 52 months
safety and tolerability
Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE v5), vital signs (pulse and blood pressure), clinical laboratory, physical examination, ECG parameters, LVEF, and ECOG Performance Status.
Time frame: Approximately 52 months
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Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan
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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2030, 47 months after the start.
Of 43 phase 4 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 48. This study's planned 47 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Osimertinib
Carcinoma, Non-Small-Cell Lung →