Multicenter randomized phase II study of cisplatin+pemetrexed+bevacizmab followed by maintenance pemetrexied with or without bevacizmab in patients chemoterapy-naive advanced non-squamous non-small cell lung cancer with wild type EGFR(TORG1321)

Multicenter randomized phase II study of cisplatin+pemetrexed+bevacizmab followed by maintenance pemetrexied with or without bevacizmab in patients chemoterapy-naive advanced non-squamous non-small cell lung cancer with wild type EGFR(TORG1321) - Randomized phase II study of CDDP+PEM+BEV followed by maintenance PEM with or without BEV in patients with chemotherapy-naive advanced non-squamous NSCLC with wild type EGFR(TORG1321)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010681

Enrollment

Registered

2013-05-17

Start date

2013-05-27

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

Chemotherapy-naive advanced non-squamous non-samll cell lung cancer with wild type EGFR

Interventions

CDDP 75mg/m2 + PEM 500mg/m2 + BEV 15mg/kg day 1 x 4 cycles q3wks followed byPEM 500mg/m2 q3wks until PD CDDP 75mg/m2 + PEM 500mg/m2 + BEV 15mg/kg day 1 x 4 cycles q3wks followed byPEM 500mg/m2 BEV 15

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: First step(induction) 1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)Wild type EGFR 3)Stage IIIB,stageIV without any indications for radiotherapy 4)No prior chemotherapy 5)ECOG performance status 0-1 6)With one or more measurable disease (RECIST ver.1.1) 7) Aged 20<=, <=74 8)Adequate organ function 9)In case of non-chest radiation, need more than two weeks interval after last radiation 10)Written informed concent Second step (maintenance) 1)Non-PD patients after induction therapy 2)Adequate organ function after non-PD confirmation 3)ECOG performance status 0-1

Exclusion criteria

Exclusion criteria: First step(induction) 1)Symptomatic brain metastasis 2)Current history of hemoptysis 3)With pulmonary cavity lesions 4)History of radical thoracic radiotherapy 5)Active infections diseases 6)Fever over 38 degrees centigrade 7)Serious complications 8)Massive pleural and cardiac effusion and ascites that need to be immediately treated 9)Active concomitant cancers 10)Severe drug allergy 11)Uncontrollable ulcer indigestive tract 12)Perforation of the digestive tract or history within the past one year 13)Receiving anticoagulant drug (325mg and less aspirin is possible) 14) Pregnancy, breastfeeding or suspected of being pregnant 15)Those judged to be not suitable by the attending physician Second step (maintenance) 1)Symptomatic brain metastasis 2)Accompanied by serious complication in induction therapy 3) Severe drug allergy for PEM or BEM or severe adverse effect in induction therapy

Design outcomes

Primary

Measure	Time frame
Progression free survival of maintenance therapy	—

Secondary

Measure	Time frame
Progression free survival from induction therapy, Overall survival from induction and maintenance therapy, Response rate of induction and maintenance therapy, Disease control rate of induction and maintenance therapy, 1 year survival rate of induction and maintenance therapy, Safety	—

Countries

Japan

Contacts

Public ContactTakashi Kasai

Tochigi cancer center Department of respiratory medicine

takasai@tochigi-cc.jp028-658-5151

Outcome results

None listed

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