Know Cancer

forgot password

A Single-Arm, Phase 2 Trial of Pemetrexed, Cisplatin,and Bevacizumab as Induction, Followed by Pemetrexed and Bevacizumab as Maintenance, in First-Line Treatment of Nonsquamous Advanced NSCLC

Phase 2
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

Thank you

Trial Information

A Single-Arm, Phase 2 Trial of Pemetrexed, Cisplatin,and Bevacizumab as Induction, Followed by Pemetrexed and Bevacizumab as Maintenance, in First-Line Treatment of Nonsquamous Advanced NSCLC

The study will have 3 periods: a baseline period; a study treatment period, including both
induction and maintenance treatment; and a postdiscontinuation period. Approximately 110
participants will be enrolled into the study, with the aim of having 100 evaluable
participants. Eligible participants will first receive 4 cycles of induction chemotherapy
with pemetrexed-cisplatin-bevacizumab. Participants who achieve a response or do not
progress after completion of induction chemotherapy and have an adequate performance status
will receive maintenance therapy with pemetrexed-bevacizumab. Treatment will continue until
disease progression or unacceptable toxicity occurs. When treatment is discontinued, the
participants health status will be monitored till death, loss to follow-up or data cut-off

Participants who continue to receive benefit from treatment at the time of data cut-off may
receive continued access to pemetrexed and bevacizumab until disease progression,
unacceptable toxicity, or any other reason at investigator or participants decision.

Inclusion Criteria:

- Histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV NSCLC
that is not amenable to curative therapy.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- At least 1 unidimensionally measurable lesion meeting the Response Evaluation
Criteria In Solid Tumors (RECIST) criteria.

- Adequate organ function, including the following:

- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count
(ANC) >1.5 x 109/L, platelets >100 x 10^9/L, and hemoglobin > 10 g/dL.

- Hepatic: bilirubin <1.5 times the upper limit of normal (ULN);alkaline
phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase
(ALT) <3.0 x ULN (AP, AST, and ALT <5 x ULN is acceptable if liver has tumor

- Renal: calculated creatinine clearance (CrCl) >45 mL/min based on the original
weight-based Cockcroft and Gault formula, and serum creatinine <1.5 x ULN.

- At the time of enrollment, if the urinalysis dipstick result is >2+ for protein,
a 24-hour urine collection should be taken. In these cases, participants must
have <1g protein/24 hours to be eligible for study participation.

- Participants must sign an Informed Consent Document (ICD).

Exclusion Criteria:

- Have received prior systemic anticancer therapy for lung cancer (including adjuvant
early-stage treatment for NSCLC).

- Have a serious cardiac condition, such as myocardial infarction within 6 months,
angina, or heart disease, as defined by the New York Heart Association Class III or

- Have a second primary malignancy that is clinically detectable at the time of
consideration for study enrollment.

- Are receiving concurrent administration of any other antitumor therapy.

- Have a history of gastrointestinal fistula, perforation, or abscess, inflammatory
bowel disease, or diverticulitis.

- Have had significant weight loss (that is, >10%) over the previous 6 weeks before
study entry.

- Have a history of gross hemoptysis (bright red blood of >½ teaspoon per episode of
coughing) <3 months prior to enrollment or history or evidence of inherited bleeding
diathesis or coagulopathy with the risk of bleeding.

- Are taking or have recently taken (within 10 days of enrollment) full-dose oral or
parenteral anticoagulants or thrombolytic agents for therapeutic purposes.
Prophylactic use of anticoagulants is allowed; international normalized ratio (INR)
should be <1.5 at study enrollment.

- Have a history of hypertension, unless hypertension is well controlled upon study
entry (<150/90 mm Hg) and the participant is on a stable regimen of antihypertensive
therapy. Participants should not have any prior history of hypertensive crisis or
hypertensive encephalopathy.

- Have had major surgery, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment, or anticipate the need for major surgical procedure during
the course of the study.

- History of thrombotic disorders within the last 6 months prior to entry.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Time Frame:

From enrollment to the first date of objectively determined Progressive disease or death from any cause (every other cycle during study treatment, and then every 6 weeks during follow-up period)

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Denmark: Danish Medicines Agency

Study ID:




Start Date:

October 2009

Completion Date:

December 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms