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Comparison of the Efficacy of EGFR-TKI Monotherapy versus EGFR-TKI Combined with Platinum-Based Dual-Drug Chemotherapy in Neoadjuvant Therapy for Stage II-IIIB Non-Small Cell Lung Cancer: A Multicenter Retrospective Study

Comparison of the Efficacy of EGFR-TKI Monotherapy versus EGFR-TKI Combined with Platinum-Based Dual-Drug Chemotherapy in Neoadjuvant Therapy for Stage II-IIIB Non-Small Cell Lung Cancer: A Multicenter Retrospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113211
Enrollment
Unknown
Registered
2025-11-26
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Lung Cancer

Interventions

Exposed group (combination chemotherapy):EGFR-TKI administered concurrently or sequentially with platinum-based doublet chemotherapy:None
Unexposed group (monotherapy): EGFR-TKI monotherapy alone:None

Sponsors

Second Affiliated Hospital of Army Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Age 18–80 years; 2. Pathologically confirmed EGFR-sensitive mutation (19del/L858R) via biopsy; 3. Clinical stage II–IIIB (AJCC 8th edition), assessed as surgically resectable by a multidisciplinary team (MDT); 4. Treatment regimen: (1) Monotherapy group received >=2 cycles of neoadjuvant EGFR-TKI monotherapy (osimertinib/erlotinib/gefitinib); (2) Combination group received >=2 cycles of neoadjuvant EGFR-TKI plus platinum-based doublet chemotherapy (e.g., pemetrexed + cisplatin); 5. Surgical completion: Underwent radical resection (R0/R1) with evaluable pathological specimens.

Exclusion criteria

Exclusion criteria: 1. Concurrent mutations in other driver genes (e.g., ALK, ROS1, RET, etc.); 2. Disease progression (PD) during neoadjuvant therapy or failure to undergo surgery; 3. Prior history of chest radiotherapy or immunotherapy; 4. Incomplete clinical data (e.g., missing baseline imaging or pathology reports).

Design outcomes

Primary

MeasureTime frame
MPR, Major Pathological Response;Survival status (Overall Survival, Event-Free Survival);

Secondary

MeasureTime frame
Pathologic Complete Response;Drug regimen (targeted therapy, chemotherapy regimen, and treatment duration);Site and time of recurrence;Adverse events (incidence of grade >=3 immune-related adverse events [irAEs], surgical complications [Clavien-Dindo classification]);

Countries

China

Contacts

Public ContactChen Liang

Second Affiliated Hospital of Army Medical University, PLA

wanganhui1995@163.com+86 23 6877 4616

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026