Lung Cancer (NSCLC)Phase 2NCT07829744
Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations
A Phase 2 study testing Surgical Resection in people with Lung Cancer (NSCLC), run by Shanghai Zhongshan Hospital.
Trial summary
This study evaluates the effectiveness and safety of targeted therapy given before and after surgery in patients with resectable or potentially resectable stage III non-small cell lung cancer with selected genetic alterations. Treatment is assigned according to tumor genetic findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Surgical Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 30 Jun 2030
- Phase
- Phase 2
- 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
- Age ≥18 years.
- Histologically or cytologically confirmed stage III NSCLC (AJCC 8th edition), considered resectable or potentially resectable.
- Documented EGFR exon 20 insertion, ALK fusion, ROS1 fusion, MET exon 14 skipping alteration, RET fusion, or KRAS G12C mutation.
- At least one measurable lesion per RECIST 1.1 and ECOG performance status 0-1.
- Adequate cardiopulmonary and major organ function for surgery.
- Written informed consent and willingness to comply with study procedures, sample collection, and follow-up.
Who cannot join
- Stage III NSCLC considered unresectable by surgical assessment.
- Lung cancer treatment within the previous 2 years, or prior lung cancer with a remission duration of less than 2 years.
- Another malignancy within the previous 5 years.
- Major surgery within 28 days before the first study dose.
- Any contraindication to the assigned targeted therapy.
- Inability or unwillingness to provide informed consent or comply with study requirements.
About this study
This study evaluates the effectiveness and safety of targeted therapy given before and after surgery in patients with resectable or potentially resectable stage III non-small cell lung cancer with selected genetic alterations. Treatment is assigned according to tumor genetic findings.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Surgical Resection
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ResectionProcedure or surgery
Curative-intent resection following targeted therapy in participants considered suitable for surgery.
| Study group | Role | What they receive |
|---|---|---|
| EGFR Exon 20 Insertion Cohort | Experimental | Sunvozertinib Receives: Procedure: Surgical Resection |
| ALK Fusion Cohort | Experimental | Alectinib Receives: Procedure: Surgical Resection |
| ROS1 Fusion Cohort | Experimental | Entrectinib Receives: Procedure: Surgical Resection |
| MET Exon 14 Skipping Cohort | Experimental | Tepotinib Receives: Procedure: Surgical Resection |
| RET Fusion Cohort | Experimental | Selpercatinib Receives: Procedure: Surgical Resection |
| KRAS G12C Mutation Cohort | Experimental | Fulzerasib Receives: Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate
Measured: At surgery, approximately 10-12 weeks after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829744
- Sponsor's protocol ID
- B2026-011R
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations
- ClinicalTrials.gov ID
- NCT07829744
- Acronym / sponsor ID
- B2026-011R
- Conditions
- Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness and safety of targeted therapy given before and after surgery in patients with resectable or potentially resectable stage III non-small cell lung cancer with selected genetic alterations. Treatment is assigned according to tumor genetic findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| EGFR Exon 20 Insertion Cohort | Experimental | Procedure: Surgical ResectionSunvozertinib |
| ALK Fusion Cohort | Experimental | Procedure: Surgical ResectionAlectinib |
| ROS1 Fusion Cohort | Experimental | Procedure: Surgical ResectionEntrectinib |
| MET Exon 14 Skipping Cohort | Experimental | Procedure: Surgical ResectionTepotinib |
| RET Fusion Cohort | Experimental | Procedure: Surgical ResectionSelpercatinib |
| KRAS G12C Mutation Cohort | Experimental | Procedure: Surgical ResectionFulzerasib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Histologically or cytologically confirmed stage III NSCLC (AJCC 8th edition), considered resectable or potentially resectable.
- Documented EGFR exon 20 insertion, ALK fusion, ROS1 fusion, MET exon 14 skipping alteration, RET fusion, or KRAS G12C mutation.
- At least one measurable lesion per RECIST 1.1 and ECOG performance status 0-1.
- Adequate cardiopulmonary and major organ function for surgery.
Key exclusion criteria (6 listed)
- Stage III NSCLC considered unresectable by surgical assessment.
- Lung cancer treatment within the previous 2 years, or prior lung cancer with a remission duration of less than 2 years.
- Another malignancy within the previous 5 years.
- Major surgery within 28 days before the first study dose.
- Any contraindication to the assigned targeted therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical ResectionCurative-intent resection following targeted therapy in participants considered suitable for surgery. | Procedure or surgery | ALK Fusion Cohort, EGFR Exon 20 Insertion Cohort, KRAS G12C Mutation Cohort, MET Exon 14 Skipping Cohort, RET Fusion Cohort, ROS1 Fusion Cohort |
Primary outcome
Major Pathological Response Rate
Time frame: At surgery, approximately 10-12 weeks after treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgical Resection in people with Lung Cancer (NSCLC), run by Shanghai Zhongshan Hospital.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response Rate (time frame: At surgery, approximately 10-12 weeks after treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.