Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgical Resection

    Procedure/Surgery

    Curative-intent resection following targeted therapy in participants considered suitable for surgery.

Treatment groups

190 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: EGFR Exon 20 Insertion CohortExperimental treatment 1 intervention
Group B: ALK Fusion CohortExperimental treatment 1 intervention
Group C: ROS1 Fusion CohortExperimental treatment 1 intervention
Group D: MET Exon 14 Skipping CohortExperimental treatment 1 intervention
Group E: RET Fusion CohortExperimental treatment 1 intervention
Group F: KRAS G12C Mutation CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major Pathological Response Rate

Time frame
At surgery, approximately 10-12 weeks after treatment initiation.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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