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Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination With Cetuximab, IMC-A12 or Both in Patients With Advanced Non-Small Cell Lung Cancer Who Will Not Receive Bevacizumab-Based Therapy

Phase 2
18 Years
Not Enrolling
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Thank you

Trial Information

Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination With Cetuximab, IMC-A12 or Both in Patients With Advanced Non-Small Cell Lung Cancer Who Will Not Receive Bevacizumab-Based Therapy


I. To evaluate the progression-free survival of patients with NSCLC randomized to
carboplatin plus paclitaxel plus cetuximab or carboplatin plus paclitaxel plus IMC-A12
(cixutumumab) or carboplatin plus paclitaxel plus cetuximab plus IMC-A12.


I. To evaluate the response rate, disease control rate (complete response plus partial
response plus stable disease), and toxicities for each arm.

II. To evaluate EGFR by IHC, mutation, and gene copy number, IGF-1R and IGF-2R expression
(both phosphorylated and unphosphorylated states), expression of p-AKT by IHC, and k-ras

III. Plasma-based biomarkers will be evaluated for total and free insulin-like growth factor
1 and 2, IGF-growth factor binding protein 3 (IGFBP3) and circulating levels of EGF and TGF

IV. To evaluate overall survival on each of the three arms.

OUTLINE: This is a multicenter study. Patients are stratified according to gender and
histology (squamous cell vs non-squamous cell). Patients are randomized to 1 of 3 treatment

ARM I: Patients receive carboplatin intravenously (IV) over 15-30 minutes and paclitaxel IV
over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and
36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding
disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8,
15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive carboplatin and paclitaxel as in arm I. Patients also receive
cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2
courses. Patients with stable or responding disease after 2 courses proceed to maintenance
therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats
every 42 days in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also
receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients
with stable or responding disease after 2 courses proceed to maintenance therapy with
cetuximab as in arm I and cixutumumab as in arm II.

Tumor tissue samples are collected at baseline for analysis of EGFR expression by IHC,
mutation, and gene copy number; IGF-1R and IGF-2R expression (both phosphorylated and
unphosphorylated states); p-AKT expression by IHC; and k-ras mutation. Blood, serum, and
plasma samples are collected periodically for biomarker analysis.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 1 year.

Inclusion Criteria:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Stage IIIB disease

- T4, NX with nodule in ipsilateral lung lobe allowed provided patient is not
a candidate for combined chemotherapy and radiotherapy

- Stage IV disease (includes M1a and M1b)

- Measurable disease as defined by RECIST criteria

- Ineligible for or refused treatment with bevacizumab

- No small cell lung cancer or mixed small cell and NSCLC

- No untreated or symptomatic CNS metastases

- Patients with a history of CNS metastases that are definitively treated, stable,
and controlled are eligible provided the following criteria are met:

- Definitive therapy (surgery and/or radiotherapy) has been administered

- Not planning to undergo additional treatment for brain metastases

- Clinically stable

- Off corticosteroids or on a stable dose of corticosteroids for ≥ 14 days
before study entry

- ECOG performance status 0-1

- Leukocytes > 3,000/mm^3

- ANC > 1,500/mm^3

- Hemoglobin > 9 g/dL

- Platelet count > 100,000/mm^3

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST < 3 times ULN (< 5 times ULN if elevations due to liver metastases)

- Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min

- Fasting serum glucose < 120 mg/dL

- PTT ≤ 1.2 times ULN and INR ≤ 1.5 (unless patient is on anticoagulation therapy)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after the
last dose of cixutumumab

- No poorly controlled diabetes mellitus

- Patients with a history of diabetes mellitus are eligible provided their blood
glucose is within normal range and they are on a stable dietary or therapeutic
regimen for this condition

- No peripheral neuropathy > grade 1 as per CTCAE v 4.0

- No history of or suspected interstitial pneumonitis or pulmonary fibrosis on imaging

- No significant uncontrolled cardiac disease within the past 6 months, including any
of the following:

- Uncontrolled hypertension (BP > 150/100 mm Hg)

- Unstable angina

- Recent myocardial infarction

- Uncontrolled congestive heart failure

- Cardiomyopathy with decreased ejection fraction

- No arterial thrombosis, pulmonary embolus, deep vein thrombosis, or hemorrhagic
disorders within the past 28 days

- No other prior or concurrent malignancy, except for the following:

- Curatively treated malignancy with no known active disease for ≥ 3 years AND is
considered to be at low risk for recurrence by the treating physician

- Adequately treated nonmelanoma skin cancer or lentigo maligna with no evidence
of disease

- Adequately treated cervical carcinoma in situ with no evidence of disease

- Prostatic intraepithelial neoplasia with no evidence of prostate cancer

- No history of any medical or psychiatric condition, addictive disorder, or laboratory
abnormality that, in the opinion of the investigator, may increase the risks
associated with study participation or study treatments or may interfere with the
conduct of the study or interpretation of study results

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to cixutumumab

- Concurrent therapeutic anticoagulation allowed provided there is no bleeding and
patient is on a stable dose of anticoagulation therapy (e.g., Warfarin with an INR of
2-3) for > 2 weeks prior to study entry

- No prior agents targeting the EGFR or IGFR pathways

- No prior therapy for advanced NSCLC, except for surgery and/or radiotherapy

- No prior systemic therapy, including bevacizumab for advanced stage NSCLC

- At least 21 days since prior radiotherapy

- More than 4 weeks since prior major surgery or hormonal therapy (other than hormone
replacement therapy) and recovered

- More than 1 year since prior neoadjuvant or adjuvant chemotherapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

From randomization to death or disease progression, whichever occurs first, assessed up to 3 years

Safety Issue:


Principal Investigator

Nasser Hanna

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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