48 results
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 investigate if CVL-865 decreases subjective anxiety symptoms elicited by a 35% CO2 inhalation challenge.Secondary: To investigate if CVL-865 decreases subjective fear symptoms elicited by a 35% CO2 inhalation challenge. To investigate if…
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…
Part 1:Primary Objective- To investigate whether repeated dose GRX-917 reduces panic symptoms elicited by an experimental 35% CO2 -induced fear challenge administered in healthy CO2-sensitive subjects. Secondary Objectives- To investigate whether…
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)
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…
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…
The overall main objective is to develop a safe and effective individualized dosing regimen for pemetrexed.
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).…