NCI Community Oncology Research Program - Protocol Summary
SWOG S1400K - "A Phase II Study of ABBV-399 in Patients with C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY)"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Lung Clinical Trial
CANCER TYPE: Non-Small Cell - Stage IV
RESEARCH BASE: SWOG
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
Stage IV or recurrent,C-Met positive, SCCA, ABBV-399. DCP-001 Eligible
ABBV-399 2.7mg/kg, IV, day 1
Cycle = 21 days
Sub-Study Specific Eligibility
- Patients must be assigned to S1400K. The c-Met testing will be performed at a protocol specified central laboratory. S1400K biomarker eligibility defined as C-Met positive squamous cell is as follows: c-Met IHC positive based on Ventana SP44 Assay (H score ≥150)
- Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration.
- Patients must not have peripheral edema > Grade 1, or peripheral neuropathy > Grade 1 at the time of sub-study registration.
- Patients must not have received prior treatment with c-Met pathway inhibitors.
- Patients must not be taking strong CYP3A4 inhibitors within 7 days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment. (see S1400K Section 7.2).
- Patients must have albumin ≥ 3.0 g/dL within 28 days prior to sub-study registration.
- Patients must have adequate hepatic function as defined by serum bilirubin ≤ Institutional Upper Limit of Normal (IULN) and either ALT or AST ≤ 2.5 x IULN (if both ALT and AST are done, both must be < 2.5 IULN) and gamma-glutamyl transferase (GGT) ≤5 x ULN within 28 days prior to sub-study registration. [This criterion replaces common eligibility criteria in S1400K Section 5.3i]
- Patients with extensive metastatic liver disease involving ≥ 50% of the liver in the judgment of the Investigator or sum of longest diameters of RECIST measurable liver lesions ≥10 cm will not be enrolled. [This criterion replaces common eligibility criteria in S1400K Section 5.3i]
- Patients must not be pregnant or nursing.
- Patients must agree to have blood specimens submitted for pharmacokinetic analysis as outlined in S1400K Section 15.3.
- Patients must also be offered participation in banking for future use of specimens as described in S1400K Section 15.0.
Common Eligibility Criteria for all Sub-Studies
- Patients whose biomarker profiling results indicate the presence of an EGFR mutation or EML4/ALK fusion are not eligible.
- Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy.
- Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration. Patients must have recovered (≤ Grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration.
- Patients must have measurable disease (see S1400K Section 10.1) documented by CT or MRI.
- Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study registration. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration.
- Patients must have fully recovered from the effects of surgery at least 14 days prior to sub-study registration.
- Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
- Patients must have an ANC ≥ 1,500/mcl, platelet count ≥ 100,000 mcl, and hemoglobin ≥ 9 g/dL obtained within 28 days prior to sub-study registration.
- Patients must have a serum creatinine ≤ the IULN OR measured OR calculated creatinine clearance ≥ 50 mL/min using the following Cockroft-Gault Formula.
- Patients must have Zubrod performance status of 0-1 (see S1400K Section 10.4) documented within 28 days prior to sub-study registration.
- Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia (see S1400K Section 18.4).
- Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection.
- Patients with a known history of HIV seropositivity:
- Must have undetectable viral load using standard HIV assays in clinical practice.
- Must have CD4 count ≥ 400/mcL.
- Must not require prophylaxis for any opportunistic infections (i.e., fungal, MAC, or PCP prophylaxis).
- Must not be newly diagnosed within 12 months prior to sub-study registration.
- Prestudy history and physical exam must be obtained within 28 days prior to sub-study registration.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
- As a part of the OPEN registration process (see S1400 Section 13.4 for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
- Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator).
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.