A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)

A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non-Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101) - A Phase 2 Study of Carboplatin, Pemetrexed, and Bevacizumab followed by Bevacizumab and Erlotinib maintenance for Non-squamous Non Small Cell Lung Cancer not harboring EGFR mutations. (HOT1101)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005872

Enrollment

Registered

2011-06-28

Start date

2011-06-01

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

Non-small cell lung cancer

Interventions

Pemetrexed+Carboplatin+Bevacizumab followed by maintenance Erlotinib+Bevacizumab until disease progression

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Age: 20-74 years 2)Histologically or cytrologically confirmed diagnosis of non-squamous non-small cell lung cancer (non-squamous NSCLC). 3)Stage IIIB/IV or postoperative recurrence 4)No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last administration of adjuvant chemotherapy. 5)Patients who have measurable lesions. 6)Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2. 7)Adequate function of main organ. White blood cell count>=3000/mm3 Absolute granulocyte count >= 1500/mm3 Hemoglobin >= 9.0g/dL Platelet count >= 100,000/mm3 Serum bilirubin <= 1.5 mg/dL AST,ALT <100 IU/l Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min PaO2(Room air) >=60Torr (or SpO2>=95%) Proteinuria<1+ 8)Life expectancy more than 3 months 9)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Previous histories of drug allergy, which may increase the risk of this study. 2)Serious concomitant infection. 3)Usages of oral steroids or immunosuppressive drugs. 4)Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes. 5)Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 6)Patients with EGFR mutation. 7)Severe pleural, abdominal or cardiac effusion. 8)Prior to study entry major surgical procedures within 3 weeks or prior systemic therapy to contain radiotherapy within 2 weeks. 9)Patient in acknowledgment of hemoptysis (2.5 ml or more) or clinically important bleeding or a clot-related event. 10)No uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 90 mmHg). 11)Symptomatic brain metastasis. 12)The patient that the tumor permeation to chest great vessels is accepted. 13)cavity in tumor. 14)receiving anticoagulant drug(except Aspirin under 325mg/day). 15)Patients with active concomitant malignancy. 16)Pregnant, lactating women. 17)Inappropriate patients judged by physicians.

Design outcomes

Primary

Measure	Time frame
Progression-free survival at 6 months	—

Secondary

Measure	Time frame
Response rate Shift ratio to maintenance therapy Overall survival Safety	—

Countries

Japan

Contacts

Public ContactNoriyuki Yamada

Hokkaido University First Department of Medicine

ymda3nr222@gmail.com011-706-5911

Outcome results

None listed

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