Efficacy and safety of gefitinib plus bevacizumab as first-line therapy in patients with advanced non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPN-16010148

Enrollment

Unknown

Registered

2016-12-14

Start date

2017-01-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Non-small cell lung cancer

Interventions

Gef+Bev group:bevacizumab plus gefitinib

Eligibility

Sex/Gender

All

Age

15 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Signed Informed Consent Form. Life expectancy>=12 weeks. Eastern Cooperative Oncology Group performance status 0-2. Able to comply with the study protocol in the investigators judgment; 2. Histologically or cytologically documented inoperable, locally advanced (Stage IIIb who are not amenable for combined modality treatment), metastatic (Stage IV); 3. An exon 19 deletion mutation or exon 21 L858R mutation has been found by ARMS test; 4. Not receive chemotherapy or other systemic anti-tumor treatment, routine blood, liver and kidney function in various clinical parameters and ecg examination basic normal.

Exclusion criteria

Exclusion criteria: (1) Mixed adenosquamous carcinomas with predominantly squamous component; (2) Evidence of tumour invading major blood vessels on imaging; (3) History of haemoptysis, defined as >10ml of red blood per event within 3 months prior to randomization. History or evidence of inherited bleeding diathesis or coagulopathy that increases the risk of bleeding; (4) Major surgery (including open biopsy) or significant traumatic injury within 30 days prior to randomization or anticipation of the need for major surgery during study treatment; (5) Uncontrolled hypertension (blood pressures: systolic>160 mmHg and/or diastolic >100 mmHg); Prior history of hypertensive crisis or hypertensive encephalopathy; Clinically significant (i.e., active) cardiovascular disease; (6) Known hypersensitivity to bevacizumab and Chinese hamster ovary cell products or other recombinant human or humanised antibodies or gefitinib or any of its excipients.

Design outcomes

Primary

Measure	Time frame
Progression-free survival;	—

Secondary

Measure	Time frame
Overall Response Rate;Disease Control Rate;Objective response rate;	—

Countries

China

Contacts

Public ContactLu Huiyu

Taizhou people's hospital

tzhuxi888@sina.com+86 13775667788

Outcome results

None listed

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