New combo therapy aims to control returning lung cancer in targeted patients
NCT ID NCT07279935
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study is for people with a specific type of lung cancer (EGFR-mutant) that has spread to other parts of the body after they finished a previous treatment (osimertinib). The goal is to see if combining osimertinib with chemotherapy can help control the cancer for longer. About 100 participants in China will receive this combination and be monitored for how long the cancer stays stable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
May 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
24 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Research Site
NOT_YET_RECRUITINGBeijing, 100021, China
-
Research Site
RECRUITINGBeijing, 100044, China
-
Research Site
RECRUITINGBeijing, 100142, China
-
Research Site
NOT_YET_RECRUITINGChengdu, 610031, China
-
Research Site
RECRUITINGChengdu, 610041, China
-
Research Site
RECRUITINGChongqing, 400016, China
-
Research Site
RECRUITINGFuzhou, 350001, China
-
Research Site
RECRUITINGFuzhou, 350005, China
-
Research Site
NOT_YET_RECRUITINGGuangzhou, 510080, China
-
Research Site
WITHDRAWNGuangzhou, 510100, China
-
Research Site
NOT_YET_RECRUITINGGuangzhou, 510289, China
-
Research Site
RECRUITINGHangzhou, 310016, China
-
Research Site
RECRUITINGHefei, 230022, China
-
Research Site
WITHDRAWNHefei, 230031, China
-
Research Site
WITHDRAWNJinan, 250014, China
-
Research Site
RECRUITINGJinan, 250014, China
-
Research Site
WITHDRAWNKunming, 650118, China
-
Research Site
RECRUITINGNanchang, 330006, China
-
Research Site
WITHDRAWNNanjing, 2100008, China
-
Research Site
RECRUITINGNanjing, 210009, China
-
Research Site
RECRUITINGNingbo, 315010, China
-
Research Site
RECRUITINGShanghai, 200030, China
-
Research Site
WITHDRAWNShanghai, 200120, China
-
Research Site
WITHDRAWNShanghai, 200433, China
-
Research Site
RECRUITINGShenyang, 110004, China
-
Research Site
RECRUITINGShenyang, 110042, China
-
Research Site
RECRUITINGTianjin, 300060, China
-
Research Site
RECRUITINGWuhan, 430022, China
-
Research Site
RECRUITINGWuhan, 430030, China
-
Research Site
RECRUITINGXi'an, 710004, China
-
Research Site
WITHDRAWNXi'an, 710061, China
-
Research Site
RECRUITINGZhengzhou, 450008, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer