Active — Not RecruitingPhase 2

Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC

China32 participantsStarted 2024-04-01

Plain-language summary

Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female，Age: 18 Years and older,
✓. Subjects voluntarily joined the study and signed informed consent,
✓. pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition),
✓. ECOG PS=0 or 1,
✓. resectable or potentially resectable, or resectability discussed by MDT,
✓. harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q
✓. measurable lesion as per RECIST1.1.

Exclusion criteria

✕. pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer,
✕. non small cell lung cancer harboring other driver gene alteration with approved targeted drugs,
✕. with malignant plural effusion,
✕. previous treatment to non small cell lung cancer other than this regimen,
✕. received thoracic radiotherapy,
✕. currently enrolled in other clinical trial,
✕. active or known or suspected autoimmune disease.

What they're measuring

Major Pathological Response (MPR)

Timeframe: MPR will be assessed within 2 weeks after surgery

Trial details

NCT IDNCT06300424

SponsorGuangdong Provincial People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-26

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials