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Phase I study of Erlotinib with Cisplatin, Pemetrexed, and Bevacizumab for chemotherapy naive advanced non-squamous non small cell lung cancer harboring EGFR mutation

Phase I study of Erlotinib with Cisplatin, Pemetrexed, and Bevacizumab for chemotherapy naive advanced non-squamous non small cell lung cancer harboring EGFR mutation - Quartet trial for chemo-naive advanced non-SQ NSCLC harboring EGFR mutation

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012536
Enrollment
12
Registered
2013-12-10
Start date
2013-12-11
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

advanced non squamous non small cell lung cancer

Interventions

Level0: erlotinib (150mg/day) and cisplatin (50mg/m2),pemetrexed (500mg/m2), bevacizumab (15mg/kg) Level1: erlotinib (150mg/day) and cisplatin (60mg/m2),pemetrexed (500mg/m2), bevacizumab (15mg/kg)

Sponsors

Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histology/cytology-proven non-squamous non small cell lung cancer 2)NSCLC harboring mutations of EGFR 3)Stage IIIB, IV 4)Chemotherapy naive patients 5)Performance status(ECOG): 0-1 6)Adequate organ function 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Serious infections 2)Serious clinical problems 3)Interstitial pneumonia/lung fibrosis on chest CT 4)Active concomitant malignancy 5)Symptomatic brain metastasis 6)Massive pericardial, pleural effusion, ascites 7)Previous drug allergy 8)not adequated for bevacizumab 9)Those judged to be not suitable by the attending physician

Design outcomes

Primary

MeasureTime frame
To examine the dose limiting toxicity (DLT)To determine the maximum tolerated dose (MTD) and recomended dose (RD )

Secondary

MeasureTime frame
efficacy, toxicity, PFS, OS

Countries

Japan

Contacts

Public ContactMotohiro Tamiya

Osaka Prefectural Medical Center for Respiratory and Allergic diseases Thoracic Malignancy

moto19781205@yahoo.co.jp+81729572121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026