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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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

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

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 groups in NCT07829744
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.

20 Sep 202630 Jun 2030

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.
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)

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

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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