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Phase II study of Pemetrexed and Cisplatin plus Bevacizumab with Maintenance Pemetrexed as First-Line Therapy for Nonsquamous Non-small-cell Lung Cancer (ALCT001)

Phase II study of Pemetrexed and Cisplatin plus Bevacizumab with Maintenance Pemetrexed as First-Line Therapy for Nonsquamous Non-small-cell Lung Cancer (ALCT001) - Phase II study of PEM and CDDP plus Bev with Maintenance PEM as First-Line Therapy for Non-sq NSCLC (ALCT001)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010804
Enrollment
25
Registered
2013-05-25
Start date
2010-11-23
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

Nonsquamous Non-small-cell Lung Cancer

Interventions

Pemetrexed and Carboplatin plus Bevacizumab with maintenance pemetrexed as first-line therapy

Sponsors

Kyorin Univercity Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) histologically or cytologically confirmed 2)newly diagnosed stage IIIB,IV 3)recurrent NSCLC for which they had not received chemotherapy 4)measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors 5)ECOG Performance status 0-1 6)age 20-74 years 7)Patients expected to survive longer than at least three months 8)adequate hematologic, hepatic, and renal functions 9)Patients who provide written informed consent

Exclusion criteria

Exclusion criteria: 1)active or symptomatic interstitial lung disease 2)clinically significant cardiovascular disease and DVT 3)medically uncontrolled hypertension and diabetes 4)clinically significant infectious disease 5)history of diverticulitis or clinically significant diverticular disease 6)history of gross hemoptysis (2.5ml) 7)primary tumor in close proximity to a major vessel 8)primary tumor with cavitation 9)melena 10)regular use of aspirin 11)proteinuria(Grade2) 12)history of thrombotic or hemorrhagic disorder 13)uncontrollable pleural effusion and ascites 14)symptomatic brain metastasis 15)active double cancer 16)pregnancy or lactation

Design outcomes

Primary

MeasureTime frame
The primary end point of this study was PFS, defined as the time from registration to the time of documented disease progression.

Secondary

MeasureTime frame
Safety,Response rate,Disease control rate,OS,1-year survival rate,QOL

Countries

Japan

Contacts

Public ContactTakuma Yokoyama

Kyorin Univercity Hospital Department of Respiratory Medicine

taku@ks.kyorin-u.ac.jp0422-47-5511

Outcome results

None listed

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