Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: EGFR Exon 20 Insertion Cohort
Sunvozertinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
Eksperimentel: ALK Fusion Cohort
Alectinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
Eksperimentel: ROS1 Fusion Cohort
Entrectinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
Eksperimentel: MET Exon 14 Skipping Cohort
Tepotinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
Eksperimentel: RET Fusion Cohort
Selpercatinib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
|
Eksperimentel: KRAS G12C Mutation Cohort
Fulzerasib |
Curative-intent resection following targeted therapy in participants considered suitable for surgery. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Major Pathological Response Rate
Tidsramme: At surgery, approximately 10-12 weeks after treatment initiation.
|
At surgery, approximately 10-12 weeks after treatment initiation.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B2026-011R
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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