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Multicentre, prospective, real-world clinical study of afatinib or gefitinib in combination with first-line chemotherapy for advanced EGFR mutant non-squamous NSCLC

Multicentre, prospective, real-world clinical study of afatinib or gefitinib in combination with first-line chemotherapy for advanced EGFR mutant non-squamous NSCLC

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047133
Enrollment
Unknown
Registered
2021-06-08
Start date
2021-05-31
Completion date
Unknown
Last updated
2022-01-24

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

Conditions

Lung cancer

Interventions

Induction therapy with afatinib combined with pemetrexed/platinum-based chemotherapy group:Nil
Induction therapy with gefitinib combined with pemetrexed/platinum-based chemotherapy group:Nil

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Non-squamous NSCLC patients confirmed by imaging and histopathology as III B to IV stage; 2.Positive EGFR gene mutation (including 19DEL, 21L858R, G719A, G719C, G719S, L861Q, V689M, N700D, E709K/Q, S720P, L858R, N826S, A839T, K846R, G863D, G719X, S768I complex mutation, G719X complex mutation, etc.); 3.Has not received any previous systemic anti-tumor therapy; 4.No brain metastases, or asymptomatic brain metastases, or symptomatic brain metastases are treated and stable.

Exclusion criteria

Exclusion criteria: 1.Patients with wild type EGFR gene; 2.Do not receive chemotherapy or are estimated to be intolerable to chemotherapy; 3.Previous chemotherapy or EGFR-TKIs treatment; 4.Patients received adjuvant or neoadjuvant therapy and the time from the last treatment to recurrence was less than 6 months; 5.The Investigator considers the patient unsuitable for participation in any other condition of the study.

Design outcomes

Primary

MeasureTime frame
progression free survival;safety and tolerability characteristics;

Secondary

MeasureTime frame
overall survival;objective remission rate;disease control rate;

Countries

China

Contacts

Public ContactWang Zhehai

Shandong Cancer Hospital

sdzlllh803@126.com+86 531 67626929

Outcome results

None listed

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