Precise neoadjuvant therapy for locally advanced non-small cell lung cancer: a prospective, observational, umbrella trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100053021

Enrollment

Unknown

Registered

2021-11-09

Start date

2021-12-01

Completion date

Unknown

Last updated

2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced non-small cell lung cancer

Interventions

EGFR rare mutation group:Osimertinib

EGFR19del group:Almonertinib

EGFR21L858R group:Furmonertinib

Other driven mutations group:Ensartinib/Savolitinib/Pralsetinib/Pyrotinib

PD-L1>=1% group:Camrelizumab+chemotherapy

PD-L1<1% group:Chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years; 2.Histologically or cytologically confirmed NSCLC; 3.Previously untreated NSCLC including local treatment (surgery or radiotherapy) and systemic anticancer therapy including chemotherapy, targeted therapy (TKI or monoclonal antibody), cell therapy, immunotherapy, Chinese medicine therapy and others; 4.Stage II-IIIB N2 NSCLC confirmed according to the eighth TNM classification of AJCC and evaluated by MDT for the feasibility of completely surgical resection (N2 disease detected by CT or PETCT should be confirmed by mediastinoscopy or endobronchial ultrasonography); 5.Sufficient tumor tissue (not cytology specimens) available for molecular marker analyses (NGS); 6.At least one measurable lesion on spiral CT/PETCT according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). 7.Eastern Cooperative Oncology Group (ECOG) Zubrod Performance Status (ZPS) 0-1 point; 8.Patients should be tolerance of neoadjuvant therapy and thoracic surgery, and pulmonary ventilation function should be FEV1>=1.2L or anticipated FEV1 >= 800ml before receiving lobectomy, bilobectomy, sleeve lobectomy or pneumonectomy.

Exclusion criteria

Exclusion criteria: 1. Only patients who can receive sublobar resection, including segmentectomy or wedge resection; 2. Patients with mixed small cell lung cancer; Patients with malignancies other than NSCLC within 3.5 years.

Design outcomes

Primary

Measure	Time frame
objective response rate;	—

Secondary

Measure	Time frame
major pathological remission;complete pathological remission;recurrence-free survival;overall survival;Perioperative outcome;	—

Countries

China

Contacts

Public ContactFang Wentao

Shanghai Chest Hospital

vwtfang@hotmail.com+86 13901867516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026