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Small Cell Lung Carcinoma clinical trials

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NCT ID: NCT02876081 Withdrawn - Clinical trials for SMALL CELL LUNG CARCINOMA

Phase II Study of Afatinib as Third- or Further-line Treatment for Patients With Stage IV Bronchial Adenocarcinoma, Harboring Wild-type EGFR, Expressing the Neurotensin - Neurotensin Receptor Complex

THEN
Start date: September 1, 2017
Phase: Phase 2
Study type: Interventional

Lung cancer is the leading cause of cancer deaths in France, Europe and the world. 50% of lung cancers are of the adenocarcinoma subtype. 60% of patients present with a metastatic disease (stage IV) at the time of diagnosis. Approximately 10% of patients present with a mutation of the epidermal growth factor receptor (EGFR) requiring an EGFR tyrosine kinase inhibitor (EGFR-TKI), namely erlotinib, gefitinib or afatinib. For the majority of chemotherapy-naïve patients without addictive mutation, platinum-based chemotherapy, frequently the platinum - pemetrexed doublet, provides disease control rate of up to 70% and improves survival from approximately 4.5 with best supportive care alone to 15 months. However, patients with non-small cell lung cancer (NSCLC) usually relapse within 4 to 6 months and benefit from a second-line chemotherapy. Authorized drugs in this setting are pemetrexed, docetaxel and erlotinib. The prescription of erlotinib for unselected patients whose tumor does not harbor an EGFR mutation is questionable . In the second line setting, docetaxel provides less than 10% of partial responses and progression-free survival of 10 to 12 weeks. There are no standard options following failure of two previous lines of standard chemotherapy. In view of these modest results, new agents and therapeutic strategies are greatly needed for this patient population. Neurotensin (NTS) is a 13 amino acids peptide, present and biologically active in the central nervous system and in periphery. At the peripheral level, NTS is released by the endocrine cells of the intestinal mucosa after meals and acts as an endocrine hormone involved in the postprandial regulation of the motor functions of the gastrointestinal tract. The effects of NTS are mediated by three subtypes of receptor: NTSR1 and NTSR2 exhibit high and low affinity for NTS, respectively, and belong to the family of G protein receptors; NTSR3 is a single transmembrane domain receptor. Exogenous activation of NTSR1 leads to cell proliferation, survival, mobility and invasion in cancer cells from diverse origin. These effects are the result from the activation of kinases and effectors, such as PKC, MAPK, FAK, RHO-GTPase, RAS and Src. The PKC activation may induce MAPK by direct stimulation of Raf-1, or by transactivation of the EGFR. The activation of MAPK via NTSR1 is mainly associated with uncontrolled cell growth. Both NTS and NTSR1 are expressed in 40% of lung tumors, whereas they are never expressed in the normal tissue. NTSR1 high expression is a negative prognostic factor in stage I to III operated lung adenocarcinomas. Sustained stimulation of NTSR1 results in the activation of MMP1, the release of EGF "like" ligands such as HB-EGF as well as neuregulin 1 NGR1 (a specific ligand for HER3) followed by EGFR, HER2 and HER3 overexpression and activation. Accordingly, xenografted tumors expressing NTS and NTSR1 show a positive response to erlotinib, whereas tumors void of NTSR1 expression have no detectable response. Afatinib (BIBW2992) is a small molecule, selective and irreversible erbB family blocker. In preclinical models it effectively inhibits EGFR, HER2 and HER4 phosphorylation resulting in tumour growth inhibition and regression of established subcutaneous tumours derived from four human cell-lines known to co-express ErbB receptors. Our claim is that patients harbouring the NTS/NTSR complex, without EGFR mutation, will respond to afatinib due to the sustained activation of EGFR/HER2 under neurotensin activation. Presently, only EGFR mutated tumors are eligible to receive EGFR TKI representing 10% of all lung cancer patients. The aim of this study is to evaluate the efficacy of afatinib, an EGFR TKI, on lung adenocarcinomas, EGFR wild-type, bearing the NTS/NTSR1 complex with a high level of expression. This subpopulation of patients represents approximately 20% of lung adenocarcinomas.

NCT ID: NCT02661100 Withdrawn - Clinical trials for Non Small Cell Lung Cancer

A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study will look at the safety of the combination of three drugs (CDX-1401, Poly-ICL, and Pembrolizumab) and its effect on decreasing tumors. Pembrolizumab is an experimental cancer drug. CDX-1401 is a tumor specific antigen and Poly-ICL is a Toll-like receptor agonist tumor specific antigens which when combined with Pembrolizumab may increase the tumor response to this drug.

NCT ID: NCT02567396 Withdrawn - Clinical trials for Head and Neck Squamous Cell Carcinoma

Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction

Start date: June 2016
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of talazoparib in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery and liver or kidney dysfunction. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT02542137 Withdrawn - Clinical trials for Small Cell Lung Cancer

Abscopal Effect for Metastatic Small Cell Lung Cancer

Start date: September 2015
Phase: Phase 2
Study type: Interventional

Patients with small cell lung cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study. 1. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic small cell lung cancer patients. 2. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic small cell lung cancer patients; 3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect. This study will help find out what abscopal effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic small cell lung cancer.

NCT ID: NCT02425072 Withdrawn - Clinical trials for Small Cell Lung Cancer

NovoTTF-100A Therapy for Refractory CNS Involved Small Cell Lung Cancer

Start date: April 2016
Phase: Phase 2
Study type: Interventional

The hypothesis of this study is that the addition of NovoTTF-100A System treatment to salvage chemotherapy will significantly increase time to treatment failure in the brain of small cell lung cancer patients.

NCT ID: NCT02250404 Withdrawn - Clinical trials for Small Cell Lung Cancer

Molecular Signatures of Relapse in Tissue Samples From Patients With Small Cell Lung Cancer Who Are Receiving Cisplatin and Etoposide

Start date: August 22, 2014
Phase:
Study type: Observational

This pilot research trial studies molecular signatures of the return of cancer after a period of improvement (relapse) in tissue samples from patients with small cell lung cancer who are receiving or planning to receive cisplatin and etoposide. Studying samples of tissue from patients with small cell lung cancer in the laboratory may help doctors learn more about the changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer relapse.

NCT ID: NCT02152059 Withdrawn - Clinical trials for Small Cell Lung Cancer

A Study to Evaluate the Good and Bad Effects of BIBF1120 in Small Cell Lung Cancer Patients Who Have Previously Benefited From First-line Platinum-based Chemotherapy

Start date: July 2014
Phase: Phase 2
Study type: Interventional

This study is being done to evaluate the good and bad effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients and to see if BIBF1120 may or may not be more effective and better tolerated than standard therapy. The purpose of this study is to: - Find out the proportion of patients with their small small cell lung cancer controlled for at least 90 days after treatment with BIBF1120 - Compare the response rate, survival and side effects of BIBF1120 in recurrent, platinum-sensitive small cell lung cancer patients - Identify a group of patients who will benefit the most from BIBF1120 In this study, patients will receive BIBF1120 at 200 mg twice daily continuously. A cycle will be 21 days. During treatment, the dose of BIBF1120 will be held or reduced to lower doses if patients do not tolerate it well or if the doctors are concerned about the side effects of BIBF1120 on individual patients.

NCT ID: NCT02030184 Withdrawn - Clinical trials for Small Cell Lung Cancer (SCLC)

Phase I/II Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas

Start date: June 2017
Phase: Phase 1/Phase 2
Study type: Interventional

There are two parts to this trial. The first study will evaluate increasing doses of Re188 P2045 in patients with advanced small cell lung cancer that has recurred after initial therapy or in patients with other advanced neuroendocrine cancers that have progressed after therapy. Re188 P2045 is designed to attach to type 2 somatostatin receptors that are frequently expressed in those cancers and then the radioactivity from Re188 will kill the cancer cell. Only patients who have cancers that can be seen when Tc99 P2045 is administered (also seeks out the SSTR2, but Tc99 images, but does not treat the cells) will be treated. Therefore, this approach maximizes the possibility that patients will benefit from treatment in that only those who have cancers that have the target will undergo treatment. The primary purpose of this study will be to determine the highest dose of Re188 P2045 that can be safely administered. The second study will open after the conclusion of the first. Patients will first undergo the scan with Tc99 P2045 and then be treated with topotecan for three days. Topotecan is a standard chemotherapy drug that is approved for second line therapy for small cell and frequently used for other neuroendocrine cancers. Following that, patients will then be re-evaluated with the Tc99 P2045 scan and if it demonstrates that the tumor is positive for SSTR2, then patients will receive Re188 P2045. The goal of this study is to determine the highest dose of Re188 P2045 that can be safely administered after topotecan as well as to determine if topotecan will increase the chance that the tumor will express SSTR2.

NCT ID: NCT01640847 Withdrawn - Clinical trials for Non-small Cell Lung Cancer

MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases

Start date: July 2012
Phase: Phase 2
Study type: Interventional

This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for patients with painful bone metastases.

NCT ID: NCT01563601 Withdrawn - Clinical trials for Extensive-stage Small Cell Lung Cancer

Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer

Start date: August 2012
Phase: Phase 3
Study type: Interventional

This is a randomized, multi-center, open-label study of approximately 24 months duration (including follow up survival) to evaluate the safety and efficacy of obatoclax mesylate in combination with carboplatin and etoposide versus carboplatin and etoposide alone in chemotherapy-naive patients with extensive-stage small cell lung cancer.