SWOG clinical trial number
S1400E
Phase II/III Randomized Study of Rilotumumab plus Erlotinib versus Erlotinib as Second Line Therapy For Biomarker Selected Patients With Squamous Cell Lung Cancer
Closed
Phase
Accrual
3%
Abbreviated Title
Lung-MAP S1400E: HGF - Rilotumumab plus Erlotinib vs. Erlotinib
Status Notes
This sub-study will be permanently closed to accrual on 11/24/2014 at 2:00 p.m. Pacific
Activated
06/15/2014
Closed
11/25/2014
Participants
Research committees
Lung Cancer
Treatment
Erlotinib
Rilotumumab
Eligibility Criteria Expand/Collapse
1. Biomarker Eligibility Rilotumumab HGF S1400E: Pts must be C-MET positive.
2. If randomized to Arm 1, pts must be willing to provide blood specimens for anti-rilotumumab antibody testing.
3. Pts must not have peripheral edema > Grade 1 at the time of sub-study randomization.
4. Pts must not have received prior treatment with MET pathway, inhibitors or EGFR inhibitors (e.g., erlotinib).
5. Pts must have total bilirubin </= 1.5 x institutional IULN within 28 days prior to sub-study randomization.
6. Pts must not have abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjorgren�s syndrome), congenital abnormality (e.g., Fuch�s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test).
7. Pts must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates.
8. Pts must not have received prior treatment of erlotinib as part of frontline platinum-containing chemotherapy.
2. If randomized to Arm 1, pts must be willing to provide blood specimens for anti-rilotumumab antibody testing.
3. Pts must not have peripheral edema > Grade 1 at the time of sub-study randomization.
4. Pts must not have received prior treatment with MET pathway, inhibitors or EGFR inhibitors (e.g., erlotinib).
5. Pts must have total bilirubin </= 1.5 x institutional IULN within 28 days prior to sub-study randomization.
6. Pts must not have abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjorgren�s syndrome), congenital abnormality (e.g., Fuch�s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test).
7. Pts must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates.
8. Pts must not have received prior treatment of erlotinib as part of frontline platinum-containing chemotherapy.
Publication Information Expand/Collapse
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S2302
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Lung Cancer
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SWOG Clinical Trial Number
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Activated
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Phase
SWOG Clinical Trial Number
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Research Committee(s)
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Activated
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