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TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral
Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic
Chemotherapy in Patients with Mutant EGFR Non-small Cell Lung Cancer
(NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase
Inhibitor (TKI) and Platinum-doublet Chemotherapy

Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…

A Randomized Open-Label Phase III Trial of MK-3475 versus Platinum based Chemotherapy in 1L Subjects with PD-L1 Strong Metastatic Non-Small Cell Lung Cancer

Primary objective:To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central radiologists* review in subjects with PD-L1 strong, 1L metastatic NSCLC treated with MK-3475 compared to standard of care (SOC…

LUME-Meso: Double blind, randomised, multicentre, phase II/III study of nintedanib in combination with pemetrexed / cisplatin followed by continuing nintedanib monotherapy versus placebo in combination with pemetrexed / cisplatin followed by continuing placebo monotherapy for the treatment of patients with unresectable malignant pleural mesothelioma

To evaluate the safety and efficacy in terms of progression-free survival (PFS) and overall survival (OS) of nintedanib + pemetrexed / cisplatin followed by nintedanib versus placebo + pemetrexed / cisplatin followed by placebo as first line…

PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF CRIZOTINIB VERSUS PEMETREXED/CISPLATIN OR PEMETREXED/CARBOPLATIN IN PREVIOUSLY UNTREATED PATIENTS WITH NON-SQUAMOUS CARCINOMA OF THE LUNG HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC;LYMPHOMA KINASE (ALK) GENE LOCUS

To demonstrate that crizotinib (Arm A) is superior to first-line chemotherapy, pemetrexed/cisplatin or pemetrexed/carboplatin (Arm B), in prolonging PFS in patients with advanced non-squamous NSCLC whose tumors harbor a translocation or inversion…

A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence: NVALT-8A

The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.

A randomized phase III study of erlotinib compared to intercalated erlotinib with cisplatinum pemetrexed as first-line therapy for advanced EGFR mutated non-small-cell lung cancer. the NVALT-17 study

Primary: To compare progression-free survival (PFS) between erlotinib alone and cisplatin-pemetrexed-erlotinib in patients with EGFR mutated NSCLC locally advanced and metastatic disease stage IIIB and IV.Secondary: To characterize toxicities of…

A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and
Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

The primary objective of the study is to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects…

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN OR CISPLATIN + PEMETREXED COMPARED WITH CARBOPLATIN OR CISPLATIN + PEMETREXED IN PATIENTS WHO ARE CHEMOTHERAPY-NAIVE AND HAVE STAGE IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

The co-primary objectives of this study are: * To evaluate the efficacy of as measured by investigator-assessed PFS according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). * To evaluate the efficacy of atezolizumab as…

A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189).

Primary Objective1. To evaluate the antitumor activity of pembrolizumab in combination with chemotherapy compared with saline placebo in combination with chemotherapy using PFS per RECIST 1.1 as assessed by BICR of imaging.2. To evaluate the…

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator*s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

The purpose of this study is to demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in participants with second- or third-line (2L-3L) cervical cancer (Overall Survival-OS)

A phase III, multicenter, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALK-rearranged (ALK-positive) advanced non-small cell lung cancer who have been treated previously with chemotherapy (platinum doublet) and crizotinib

The primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy.The key secondary objective is to compare Overall Survival (OS) in patients treated with LDK378 versus reference chemotherapy (pemetrexed or docetaxel…

A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as first line therapy for locally advanced or metastatic non-squamous and squamous non-small cell lung cancer subjects (CANOPY-1)

Primary: Safety run-in part (part 1):• Recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with pembrolizumab plus chemotherapy. Double-blind, randomized, placebo-controlled part (part 2):• Progressive free survival (PFS) between…

LIBRETTO-431: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Platinum-Pemetrexed Chemotherapy Plus Investigator*s Choice of Pembrolizumab in Patients with Advanced, Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

This study has been transitioned to CTIS with ID 2023-506783-14-00 check the CTIS register for the current data. The proposed Study J2G-MC-JZJC (hereafter referred to as JZJC) will evaluate selpercatinib in comparison to platinum-based (carboplatin…

An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)

This study has been transitioned to CTIS with ID 2023-503674-20-00 check the CTIS register for the current data. Primary objective: To assess the efficacy of T-DXd relative to platinum with pemetrexed plus pembrolizumab by assessment of PFS by BICR…

A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

This study has been transitioned to CTIS with ID 2023-509576-42-00 check the CTIS register for the current data. This Phase III study, the administration of durvalumab + chemotherapy prior to surgery, followed by administration of durvalumab after…

A Randomized, Open-Label, Phase 3 Study of Pralsetinib versus Standard of Care for First Line Treatment of RET fusion-positive, Metastatic Non-Small Cell Lung Cancer

This study has been transitioned to CTIS with ID 2023-505035-12-00 check the CTIS register for the current data

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY OF PRALSETINIB VERSUS STANDARD OF CARE FOR FIRST-LINE TREATMENT OF RET FUSION-POSITIVE, METASTATIC NON-SMALL CELL LUNG CANCER

This study has been transitioned to CTIS with ID 2023-505035-12-00 check the CTIS register for the current data. This study is designed to assess the efficacy of pralsetinib as compared to Investigator*s choice platinum-based chemotherapy regimen…

A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MeRmaiD 1)

The research hypothesis for this study is that concurrent durvalumab plus SoC chemotherapy will be more effective than placebo plus SoC chemotherapy for the treatment of MRD+ patients who have undergone complete resection of stage II-III NSCLC when…

Pembrolizumab alone versus pembrolizumab-chemotherapy in first line NSCLC

This study has been transitioned to CTIS with ID 2024-516581-11-00 check the CTIS register for the current data. Primary Objective:- to assess the effect of chemotherapy given concurrently with pembrolizumab on overall response rate (ORR) in NSCLC…

A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

Given the limited effectiveness of available EGFR TKIs in patients with NSCLC with EGFR exon 20 insertion mutations, this subset patient population is routinely treated with chemotherapy, similar to patients with no driver mutations (ie, WT EGFR).…