Tests sunvozertinib with chemotherapy in lung cancer after EGFR drug failure
Tests sunvozertinib plus chemotherapy in adults with advanced lung cancer after EGFR drug failure.
Key facts
- Who runs it
- Sichuan University
- Where
- Chengdu, ChinaSee the site
- Trial code
- Registry title
- Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 40 people, planned
- Started
- 29 Feb 2024
- Expected to end
- 30 Dec 2028
- Type of study
- Interventional
- Treatments tested
- Sunvozertinib
- Chemotherapy
- Record updated
- 8 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or spreading non-squamous lung cancer (NSCLC) with an EGFR mutation, whose cancer got worse after standard EGFR-TKI treatment.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Non-squamous non-small cell lung cancer that is locally advanced or has spread, with disease that can be measured by RECIST 1.1. Stable or already treated brain metastases are allowed.
- Earlier treatment
- The cancer must have become resistant to standard EGFR-TKI treatment, or the person could not tolerate it. No earlier chemotherapy for advanced or spreading disease.
- Biomarker or test result
- An EGFR mutation: exon 19 deletion, exon 21 L858R, or exon 20 T790M, documented by a local laboratory.
Main reasons for not taking part
- Spinal cord compression or cancer in the membranes around the brain
- Another cancer within the last 2 years
- Known resistance mutations that have an approved targeted therapy
- Stroke or bleeding in the brain within 6 months before the first dose
- Severe or poorly controlled illness, including active infections such as hepatitis B, hepatitis C or HIV
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- To provide a signed and dated, written informed consent
- 80≥Age ≥ 18 years old
- Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
- EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated
- Predicted life expectancy ≥ 12 weeks
- EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy
- No previous systemic chemotherapy for advanced or metastatic disease
- Adequate organ system function:
- Patient must have measurable disease according to RECIST 1.1
- Patients with stable or pre-treated brain metastasis (BM) can be enrolled
Who cannot take part
- With known resistant mutations that have approved target therapy
- Recover from AEs caused by previous treatment
- A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing
- A history of malignant tumors within 2 years
- Any severe or poorly controlled systemic disease per investigator's judgment active infections, including but not limited to hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency (HIV)
- Spinal cord compression or meningeal metastasis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- West China Hospital of Sichuan UniversityChengdu, ChinaContact: You Lu, MDTaking people
About the trial
What the trial wants to find out
To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.
The group in the trial
- Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)Treatment being tested
Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)
Treatment: Sunvozertinib and Chemotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I/II (WU-KONG36)
- Plain-language title
- Tests sunvozertinib with chemotherapy in lung cancer after EGFR drug failureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06195189, who can take part
- Record updated
- 8 May 2026