Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Bevacizumab

Albumin-Bound Paclitaxel

Immunomodulating Agents

Atezolizumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Bevacizumab 15 mg/kg and paclitaxel 200 mg/m² intravenously every three weeks until progression.

Atezolizumab 1200 mg, bevacizumab 15 mg/kg and paclitaxel 200 mg/m² intravenously every three weeks until progression.

Opérations Cliniques

Claire POULET, Dr

Marie Capucine WILLEMIN, Dr

Nicolas CLOAREC, Dr

Sophie SCHNEIDER, Dr

Virginie WESTEEL, Pr

Sigolène GALLAND-GIRODET, Dr

Etienne GIROUX LEPRIEUR, Pr

Jeannick MADELAINE, Dr

Philippe MASSON, Dr

Patrick MERLE, Dr

Lionel MOREAU, Dr

Isabelle MONNET, Dr

Laure FAVIER, Dr

Ayoube ZOUAK, Dr

Denis MORO-SIBILOT, Pr

Acya BIZIEUX, Dr

Cécile DUJON, Dr

Olivier MOLINIER, Dr

Arnaud SCHERPEREEL, Pr

Thomas EGENOD, Dr

Aurélie SWALDUZ, Dr

Anne MADROSZYK, Dr

Laurent GREILLIER, Pr

Benoît GODBERT, Dr

Didier DEBIEUVRE, Dr

Marion CAMPANA, Dr

Valérie GOUNANT, Dr

Jacques CADRANEL, Pr

Charles NALTET, Dr

Aldo RENAULT, Dr

Maeva ZYSMAN, Dr

Sébastien COURAUD, Pr

Clotilde DELDYCKE, Dr

Dorine TEMPLEMENT-GRANGERAT, Dr

Florian GUISIER, Pr

Sandrine HIRET, Dr

Pierre FOURNEL, Pr

Céline MASCAUX, Pr

Olivier BYLICKI, Dr

Laurence BIGAY-GAME, Dr

Delphine CARMIER, Dr

Geoffrey PAVAUT, Dr

Luc ODIER, Dr

Etienne GIROUX-LEPRIEUR, Pr

This is an open-label, randomized, non-comparative, multicentre, phase II study in which NSCLC patients who have progressed following chemotherapy and immunoptherapy are randomized to receive treatment with either paclitaxel and bevacizumab (Arm A), or paclitaxel, bevacizumab and atezolizumab (Arm B). An estimated 156 patients (52 in Arm A, 104 in Arm B) will be enrolled at approximately 40 centres. Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent or another discontinuation criterion is met. For patients in Arm B, continuation of atezolizumab beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 6 months ≤ 50% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 66% or more of patients in Arm B would achieve progression free survival at 6 months.

Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced NSCLC Progressing After Immunotherapy & Chemotherapy

A Non-comparative Randomized Phase II Trial Evaluating the Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced Non-squamous NSCLC Progressing After Immunotherapy and Chemotherapy

PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by independent review, or death due to any cause, whichever occurs first.

PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by investigator, or death due to any cause, whichever occurs first.

ORR is defined as the proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR) as determined by investigator review of radiographic disease assessments per RECIST v1.1.

OS is defined as the time from date of inclusion to the date of death due to any cause. If a death has not been observed by the date of the analysis cut-off, OS will be censored at the date of last contact.

The time until definitive health related quality of life score deterioration will be analysed using the EORTC Core Quality of Life Questionnaire (QLQ-C30).

Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).

Overall health status will also be assessed using the EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire.

Intergroupe Francophone de Cancerologie Thoracique

Symptoms and General Pathology

Neoplasm, Residual

Durvalumab

Placebo

David Spigel

Charles Swanton

This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1-defined disease recurrence, and who become MRD+ during surveillance period.

Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

DFS in FAS (using Investigator assessments according to RECIST 1.1).

Safety measures will be described as exploratory manner.

AstraZeneca

Neoplasm Metastasis

Neoplastic Processes

Radium Ra 223 dichloride

Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles.

Xofigo

Howard Safran, MD

In this study patient's will receive the medicine Xofigo which is a radioactive drug that is FDA approved to treat prostate cancer that has spread to the bones. Xofigo has not previously been tested to treat lung cancer that has spread to the bones. Your doctors are studying the effects, good and bad, of Xofigo when used to treat lung cancer that has spread to the bones.

In this study patient's will receive the medicine Xofigo which is a radioactive drug that is FDA approved to treat prostate cancer that has spread to the bones. Xofigo has not previously been tested to treat lung cancer that has spread to the bones. Your doctors are studying the effects, good and bad, of Xofigo when used to treat lung cancer that has spread to the bones. Your doctors will also be evaluating changes in health related quality of life using the EORC QL-C20 and QOL-BM22 questionnaires. They will also evaluate the impact of treatment on the Alkaline phosphate levels (by way of lab draws) in patients and measure the progression free survival and overall survival of patients with stable or responding disease after the front line chemotherapy treated with Xofigo.

BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases

BrUOG L301: Xofigo Following Frontline-Line Chemotherapy For Patients With Non-Small Cell Lung Cancer and Bone Metastases

Number of Participants with Symptomatic Skeletal Events (SSE) Receiving Xofigo With NSCLC and Bone Metastases

To measure progression-free survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo. Post 1 year of follow up the number of patients that remain stable or responding

To measure overall survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo

Rhode Island Hospital

The Miriam Hospital

Bayer

Angela Taber MD

Principal Investigator

Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.

Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles.

Xofigo: This is a radio-isotope

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Kayla Rosati

Number of Symptomatic Skeletal Events (SSE) in Patients Receiving Xofigo With NSCLC and Bone Metastases

Post 1 year of follow up the number of patients that remain stable or responding

Progression-free Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo

Overall Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo

Overall Study

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Brigatinib 180mg QD (1 x 180mg tablet) until progression

Brigatinib 180mg QD (1 x 180mg tablet) until progression + Carboplatin AUC of 5 mg/mL/min IV infusion every 3 weeks for 4 infusions + pemetrexed 500 mg/m² IV infusion every 3 weeks for 4 infusions

Patients will receive brigatinib orally at a dose of 90 mg QD for a 7 days lead-in period followed by 180 mg QD continuously, with or without food, in 28-day cycles until progression. Dose reductions are possible.

Brigatinib 180 MG

Patients will receive pemetrexed 500 mg/m² followed by carboplatin to target AUC of 5 mg/mL/min both on Day 1 as IV infusion every 3 weeks for 4 infusions. The first infusion of carboplatin and pemetrexed will be administrated at day 8 of brigatinib treatment, at time of dose escalation from 90 mg QD to 180mg QD continuously.

Michael DURUISSEAUX, Dr

Lise THIBONNIER, Dr

Jean Bernard AULIAC, Dr

Alexis CORTOT, Pr

Pascale TOMASINI, Dr

Benoit ROCH, Dr

Marie WISLEZ, Pr

Sophie BEAUCAIRE DANEL, Dr

Rémi VEILLON, Dr

Charles RICORDEL, Dr

Florian GUISIER, Dr

Judith RAIMBOURG, Dr

Charles DAYEN, Dr

Séverine FRABOULET-MOREAU, Dr

Christelle CLEMENT-DUCHENE, Dr

This is a phase II randomized, open-labelled, non-comparative multicenter study in which ALK+ NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy (Arm A) or brigatinib and carboplatin-pemetrexed therapy (Arm B). An estimated 110 patients (55 in Arm A, 55 in Arm B) will be enrolled at approximately 30 centers. A safety phase will evaluate the safety of brigatinib with carboplatin and pemetrexed treatment combination (Arm B). The first twenty-six patients enrolled in Arm B will represent the population of the safety phase. Patients will be treated until they experience progressive disease, intolerable toxicity, or another discontinuation criterion is met. Continuation of brigatinib beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 12 months ≤ 69% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 86% or more of patients in Arm B would achieve progression free survival at 12 months.

Interventional, phase II, randomized, open-labelled, non-comparative multicenter study with two parallel arms

Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)

A Phase II Randomized, Open-Labelled, Multicenter Study of Safety & Efficacy of Combination Brigatinib and Carboplatin-Pemetrexed Therapy or Brigatinib Monotherapy as First-Line Treatment in Advanced ALK-Positive Non-Small Cell Lung Cancer

Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause), determined by investigator assessment.

Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause), determined by independent review.

Proportion of patients who have achieved a best overall response of complete response or partial response (RECIST1.1), determined by investigator assessment and by independent review.

Proportion of patients who achieved progression free survival (RECIST1.1) with ALK fusion detection in ctDNA baseline liquid biopsy.

Proportion of patients who have achieved a best overall response of complete response or partial response (RECIST1.1) with ALK fusion detection in ctDNA baseline liquid biopsy.

Proportion of patients who have achieved a best overall response of complete response or partial response of the baseline measurable and non-measurable CNS disease (RECIST1.1 + RANO), determined by investigator assessment and by independent review.

Time from enrollment to first observation of progression of the baseline measurable and non-measurable CNS disease (RECIST1.1 + RANA), determined by investigator assessment and by independent review.

Change from baseline of EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) at all scheduled time points.

The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-LC13 questionnaire will be used to determine time until definitive HRQoL score deterioration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced NSCLC Progressing After Immunotherapy & Chemotherapy	NCT05781308	Non Small Cell ...	Paclitaxel Bevacizumab Atezolizumab	18 Years -	Intergroupe Francophone de Cancerologie Thoracique
Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.	NCT04642469	Carcinoma, Non-...	Durvalumab Placebo	18 Years - 130 Years	AstraZeneca
BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases	NCT02283749	Non Small Cell ...	Xofigo	18 Years -	Brown University
Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced NSCLC Progressing After Immunotherapy & Chemotherapy	NCT05781308	Non Small Cell ...	Paclitaxel Bevacizumab Atezolizumab	18 Years -	Intergroupe Francophone de Cancerologie Thoracique
BrUOG L301 With Non-Small Cell Lung Cancer and Bone Metastases	NCT02283749	Non Small Cell ...	Xofigo	18 Years -	Brown University
Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)	NCT05200481	Non Small Cell ... ALK Gene Mutati...	Brigatinib 180 ... Carboplatin Pemetrexed	18 Years -	Intergroupe Francophone de Cancerologie Thoracique

Spots Global Cancer Trial Database for ncslc

Every month we try and update this database with for ncslc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ncslc

Every month we try and update this database with for ncslc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ncslc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.