51 results
Primary phase 1: To determine MTD and/or RP2D of INC280 incombination with erlotinibPrimary phase 2: To compare the antitumor activity of INC280 alone, and INC280 in combination with erlotinib, vs platinum with pemetrexed, as measured by Progression…
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…
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…
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…
Primary Objectivea) Phase I (Safety Run-in) The primary objective of the Phase I Safety Run-in part is to investigate the safety of IO102 in combination with either pembrolizumab alone or pembrolizumab and chemotherapy (carboplatin and pemetrexed)…
Primary:To evaluate the effects of singleinhaler triple therapy (FF/UMEC/VI)compared to multiple inhaler triplecombination therapy withbudesonide/formoterol plus tiotropiumafter 12 weeks of treatment on lungfunctionOther:To evaluate the effects of…
This study is designed to assess the efficacy of pralsetinib as compared to Investigator*s choice platinum-based chemotherapy regimen for patients with metastatic NSCLC harboring an oncogenic RET fusion and who have not received prior systemic…
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…
- To assess the safety and tolerability and to determine the RP2D of T-DXd plus durvalumab in combination with cisplatin, carboplatin or pemetrexed
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…
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…
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)
Primary objective: - To evaluate the systemic absorption and pharmacokinetics of topically applied NT-077 Secondary objectives: - To evaluate the safety and tolerability of topically applied NT-077- To evaluate the pharmacodynamic effect on sweat…
This study is designed to assess the efficacy of pralsetinib as compared to Investigator*s choice platinum-based chemotherapy regimen for patients with metastatic NSCLC harboring an oncogenic RET fusion and who have not received prior systemic…
Primary objective: To assess the efficacy of T-DXd relative to platinum with pemetrexed plus pembrolizumab by assessment of PFS by BICR in participants with unresectable, locally advanced, or metastatic NSCLC harboring HER2 exon 19 or 20 mutations.
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…
• to assess the efficacy of the sequential combination strategy of front-line afatinib-chemo, followed by a treatment with osimertinib-chemo in those patients that develop a T790M mutation as a mechanism of resistance.
The proposed Study J2G-MC-JZJC (hereafter referred to as JZJC) will evaluate selpercatinib in comparison to platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab in patients with locally advanced or…
Primary objectives (Dose-escalation Phase):• To evaluate the safety and tolerability, describe the dose-limiting toxicities (DLTs), to determine the maximum tolerated dose (MTD), optimal biological dose (OBD), or highest protocol-defined dose (HPDD…
This Phase III study, the administration of durvalumab + chemotherapy prior to surgery, followed by administration of durvalumab after surgery, will be investigated in patients with resectable Stages II and III NSCLC. The efficacy of durvalumab will…