Clinical Trials Search
Phase II/III Biomarker-Driven Master Protocol for Previously Squamous Cell Lung Cancer (LUNG-MAP)(Treatment S1400A Agent MEDI4736-(Lung-MAP Sub-Study)
S1400-A
- Eligibility:Click Here to View
Substudy A eligibility:
-Patients must be assigned to this substudy.
-Patients must not have any prior exposure to immunotherapy such as, but not limited to anti-programmed cell death (PD)-1, or anti-PD-L1 antibodies. Prior exposure to the following is allowed: anti-CTLA-4 antibodies, live attenuated vaccines, anti-EGFR agents and GM-GSF.
-Patients must not have any active or prior documented autoimmune or inflammatory disease within 3 years prior to registration.
-Patients must not have any history of primary immunodeficiency. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Treatment S1400B with Agent GDC-0032 Compared to Docetaxel)
(Lung-MAP Sub-Study)
S1400-B
- Eligibility:Click Here to View
Substudy B eligibility:
-Patients must be assigned to this substudy- PI3K+
-Patients must not have Type 1 or 2 diabetes which requires anti-hyperglycemic medication
-Patients must not have active or a history of small or large intestine inflammation such as Crohn's disease or ulcerative colitis
-Patients must not require daily supplemental oxygen - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Treatment S1400C with Agent Palbociclib Compared to Docetaxel)
(Lung-MAP Sub-Study)
S1400-C
- Eligibility:Click Here to View
Substudy C eligibility:
-Patients must be assigned to this substudy defined Cell Cycle Gene Alteration Positive
-Patients must not be taking within 7 days prior to sub-study treatment arm randomization, nor plan to take while on protocol treatment drugs that are known to prolong the QT interval
-Patients must not have QTc > 480msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
-Patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of palbociclib (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Treatment S1400D with Agent AZD4547 Compared to Docetaxel)
(Lung-MAP Sub-Study)
S1400-D
- Eligibility:Click Here to View
Substudy D eligibility:
-Patients must be assigned to this substudy, defined FGFR positive
-Patients must be greater than or equal to 25 years of age (skeleton maturation is complete)
-Patients must not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology
-Patients must not have a mean resting corrected QT interval (QTc) > 450 msec obtained from 3 consecutive electrocardiograms (ECGs); any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block); nor any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age
-Patients must not be planning to receive any concomitant medication known to prolong the QT interval- -Patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD4547 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
-Patients must not have retinal detachment, previous laser treatment or intra-ocular injection for macular degeneraion, dry or wet age-related macular degeneration, retinal vein occlusion, retinel degenerative disease, or any other clinically relevant chorioretinal defect - -Patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD4547 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients with Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (LUNG-MAP NON-MATCH SUB-STUDY)
S1400-F
- Eligibility:Click Here to View
Eligibility Criteria:
-Patients must have been assigned to S1400F
-Patients must have progressed during or after prior platinum-based chemotherapy. For patients whose only prior platinum-based chemotherapy regimen was for Stage I-III disease (i.e. patient has not received any platinum-based chemotherapy for Stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy.
Patients must also have experienced disease progression during or after anti-PD-1 or anti-PD-L1 antibody monotherapy as their most recent line of treatment. Prior PD-1/PD-L1 combination therapy is not permitted.
-Prior exposure to CTLA-4 inhibitors (ipilimumab and tremelimumab) is not permitted.
-Patients must not have any history of primary immunodeficiency.
-Patients must have Zubrod performance status 0-1.***For patients that have progressed/relapse (section 14.4) and are going to continue receiving treatment they must sign an additional optional progression consent.
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (LUNG-MAP) (Treatment agent-Talazoparib)
S1400-G
- Eligibility:Click Here to View
Substudy G eligibility:
-Patients must be assigned to this substudy. Biomarker eligibility defined as Homologous Recombination Repair Deficiency positive.
-Patients must not have had prior exposure to any agent with a PARP inhibitor
-Patients must have achieved stable disease or a partial or complete response at their first disease assessment after initiating first-line platinum-based chemo.
-Patients whose biomarker profiling results indicate the presence of an EGFR mutation or EML4/ALK fusion are not eligible.
-Patients must have progressed following the most recent line of therapy.
-Patients must have recovered from side effects of prior therapy and surgery.
-Patient must have measurable disease.
-Patient must not have untreated CNS disease.
-ECOG PS must be 0-1 - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase III Randomized Study of Nivolumab plus Ipilimumab versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (S1400-I)
S1400-I
- Eligibility:Click Here to View-Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage IV SCCA or recurrent. The primary diagnosis of SCCA should be established using the current WHO/IASLC-classification of Thoracic Malignancies. Mixed histologies are not allowed.
-To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (Stages I-IV). At least one of these lines of therapy must have been a platinum-based chemotherapy regimen. Patients must have progressed following the most recent line of therapy. For patients whose prior systemic therapy was for Stage I-III disease only (i.e. patient has not received any treatment for Stage IV disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy.
-To be eligible for pre-screening, current treatment must be for Stage IV disease and patient must have received at least one dose of the current regimen. Patients must have previously received or currently be receiving a platinum-based chemotherapy regimen. Patients on first-line platinum-based treatment are eligible upon receiving Cycle 1, Day 1 infusion.
-Patients must not have a known EGFR mutation or ALK fusion.
-Patients must have Zubrod performance status 0-1 - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
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)
S1400-K
- Eligibility:Click Here to ViewSubstudy K eligibility:
- Patients must be assigned to this substudy.
-Patients must have pathologically proven squamous cell carcinoma of the lung
-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 with extensive metastatic liver disease will not be eligible. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naïve Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC)
S1403
- Eligibility:Click Here to View
*MCRC is not a selected institution for the repeat biopsy substudies.*
-Patients must have histologically or cytologically confirmed Stage IV or recurrent non-small cell lung cancer (NSCLC).
-Patients must have documented presence of an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation. T790M mutation or other molecular abnormality will be allowed as long as it accompanies one of these mutations.
-Patients must have tissue available and must agree to submission of tissue and blood
-Patients must not have received any prior systemic anticancer therapy for advanced or metastatic disease including chemotherapy or EGFR tyrosine kinase inhibitor therapy (including gefitinib, erlotinib, afatinib, or any experimental EGFR TKI agents).
-Prior chemotherapy for non-metastatic disease (i.e. adjuvant therapy or concurrent chemo-radiotherapy) is allowed as long as >12 months has passed since completion of therapy. Adjuvant EGFR-directed therapy is not allowed. Local therapy (i.e. palliative radiotherapy) is allowed as long as a period of 7 days has passed since the last dose was received and the patient has recovered from any associated toxicity at the time of registration.
-Patients may have measurable or non-measurable disease. Laboratory parameters are not acceptable as the only evidence of disease.
-Patient must not have symptomatic brain metastases or evidence of leptomeningeal carcinomatosis. Patients with asymptomatic brain metastases are eligible if off of steroids for at least 7 days prior to registration without development of symptoms.
-Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g. Crohn’s disease, malabsorption, etc).
-Patients must not have had major surgery within 28 days prior to registration or be scheduled for surgery during the projected course of protocol treatment.
-Patients must have Zubrod PS 0 - 2 - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
A Phase III Randomized Trial of Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma
S1404
- Eligibility:Click Here to View
*Credentialing required. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
Genesys Hurley, Hurley, St. John, Macomb, Sparrow, St. Alphonsus, Allegiance, Saginaw, Lehigh Valley-Patients must have completely resected melanoma of cutaneous origin or of unknown primary in order to be eligible for this study. Patients must be classified as Stage IIIA (N2a), IIIB, IIIC, or Stage IV melanoma. Patients with melanoma of mucosal or other non-cutaneous origin are eligible. Patients with melanoma of ocular origin are not eligible. Patients with a history of brain metastases are ineligible.
-Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site.
-Patients with multiple regional nodal basin involvement are eligible. Gross or microscopic extracapsular nodal extension is permitted.
-For all patients, all disease must have been resected with negative pathological margins and no clinical, radiologic, or pathological evidence of any incompletely resected melanoma. Patients must be registered within 98 days of the last surgery performed to render the patient free of disease.
-Patients may have received prior radiation therapy, including after the surgical resection. All adverse events associated with prior surgery and radiation therapy must have resolved to less than or equal to Grade 1 prior to registration.
-Patients must not have had prior immunotherapy.
-Patients must not have had previous treatment with ipilimumab
-Zubrod PS must be 0-1.
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.