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NUtritional Assessment in Non-small Cell lung cancer patients

The primary goal of this study is to gain insight changes in components of nutritional status and functional capacity over time.The objective is to improve the multidisciplinary health care for lung cancer patients.Secundary goals are to investigate…

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…

A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab plus Olaparib Combination Therapy Compared with Durvalumab Monotherapy as Maintenance Therapy in Patients whose Disease has not Progressed Following Standard of Care Platinum-Based Chemotherapy with Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION)

Primary objective:-To assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of PFS (Investigator-assessed)Secondary objectives:- To further assess the efficacy of durvalumab plus olaparib…

A Multicenter, Open label, Phase III Extension Trial to Study the Long-term
Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or
in Follow-up in a Pembrolizumab Trial.

This study has been transitioned to CTIS with ID 2022-501254-10-00 check the CTIS register for the current data. The purpose of this trial is to rollover participants who previously enrolled in MSD-sponsored pembrolizumab trials, including those who…

A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC)

Primary Efficacy Objective:Primary objective: To evaluate if the addition of ISA101b to cemiplimab results in improved overall response rate (ORR) compared to cemiplimab alone, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1…

A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab in Combination With Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN)

To assess the safety and tolerability profile of durvalumab monotherapy, durvalumab + novel oncology therapy, durvalumab + chemotherapy, anddurvalumab + novel oncology therapy + chemotherapy combinations

PD-L1 PET/CT to predict avelumab treatment response in NSCLC

The aim of the study is to develop PD-L1 PET/CT imaging in patients with NSCLC to noninvasively image PD-L1 expression in tumors and to determine the correlation with response to avelumab. For this purpose, two studies will be carried out to1:…

LUNAR: pivotal, randomized, open-label study of Tumor Treating Fields (TTFields) concurrent with standard of care therapies for treatment of stage 4 non-small cell lung cancer (NSCLC) following platinum failure

To test the efficacy and safety of TTFields, using the NovoTTF-200T System, concurrent with standard therapies for stage 4 NSCLC patients, followingprogression while on or after platinum based treatment

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy

This study has been transitioned to CTIS with ID 2023-509602-29-00 check the CTIS register for the current data. Primary objectives:- To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS- To assess the efficacy of…

Single-arm, multicenter, phase II study of immunotherapy in patients with type B3 thymoma and thymic carcinoma previously treated with chemotherapy - (Nivothym)

This study has been transitioned to CTIS with ID 2023-508658-24-00 check the CTIS register for the current data. Main objective: To assess PFS rate at 6 months in patients treated with nivolumab or the combination of nivolumab and ipilimumab, with…

A Phase Ib, Open-label, Single-center study to assess the safety of cancer-immunotherapy induction with Tremelimumab and Durvalumab prior to Chemoradiotherapy and/or Resection in the treatment of locally advanced NSCLC.

Primary Objective - To assess the safety of CIT-induction with Tremelimumab and Durvalumab, and CRT/R in stage III NSCLCSecondary objectives - To assess the efficacy of CIT-induction with Tremelimumab and Durvalumab , and CRT /R by establishing…

Phase II single arm study of afatinib in combination with cetuximab in EGFR exon 20 insertion positive non-small-cell lung cancer

• To determine the disease control rate at 18 weeks of afatinib and cetuximab treatment in patients with NSCLC harboring an EGFR exon 20 insertion mutation. • To assess anti-tumor activity of afatinib and cetuximab in NSCLC patients harboring an…

Trastuzumab-emtansine and osimertinib combination treatment to target HER2 bypass track resistance in EGFR mutation positive NSCLC

-To dertermine the objective response rate (ORR) and disease control rate (DCR) (according to RECIST v1.1) after 3 months of treatment with T-DM1 and osimertinib in patients with EGFR mutation positive NSCLC and HER2 bypass track activation-To…

Patients on osimertinib with EGFR mutation exon 20, non-T790M in lung cancer. The position-20 trial.

To determine the efficacy (as assessed by best response) of osimertinib in patients with locally advanced or metastatic NSCLC and only an EGFR exon 20 mutation, deletion and/or insertion, which are T790M-ve.

A PHASE 2, MULTICENTER, OPEN-LABEL, 2-COHORT STUDY OF TRASTUZUMAB DERUXTECAN (DS-8201a), AN ANTI-HER2 ANTIBODY DRUG CONJUGATE (ADC), FOR HER2-OVER-EXPRESSING OR -MUTATED, UNRESECTABLE AND/OR METASTATIC NONSMALL
CELL LUNG CANCER (NSCLC)

The primary objective is to evaluate the ORR of trastuzumab deruxtecan in HER2-overexpressing and/or -HER2 mutated advanced NSCLC subjects.The secondary objectives are:- To evaluate DoR, DCR, PFS, and OS.- To further evaluate the safety of…

A Phase II single-arm trial to investigate tepotinib in advanced (locally advanced or metastatic) non-small cell lung cancer with MET exon 14 (METex14) skipping alterations or MET amplification (VISION)

This study has been transitioned to CTIS with ID 2024-512003-39-00 check the CTIS register for the current data. PART 1Cohort A (METex14 skipping alterations):• To assess the efficacy of tepotinib in subjects with locally advanced or metast. (NSCLC…

18F-PD-L1 PET/CT to predict response to nivolumab in patients with NSCLC

• To assess the relation between 18F-PD-L1 PET/CT outcome measures and progression-free survival of >=9 months according to RECIST 1.1.• To assess the relation between 18F-PD-L1 PET/CT outcome measures and patient outcome in terms of PFS and…

Individualized pemetrexed dosing in patients with non-small cell lung cancer or mesothelioma based on renal function to improve treatment response - The IMPROVE-I, -II and -III studies -

The overall main objective is to develop a safe and effective individualized dosing regimen for pemetrexed.

An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in combination with Ipilimumab in Subjects with Treatment-Naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC)

Primary objectives - To evalulate the association between baseline tissue TMB/blood TMB and clinical efficacy (Objective Response Rate) for participants in Part 2- To evaluate the correlation between baseline tissue TMB and blood TMB for…

A Phase 2 Study of Poziotinib in Patients with Non-Small Cell Lung Cancer (NSCLC),
Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)

Objectives:To evaluate the following in NSCLC patients with EGFR or HER2 exon 20 insertion mutations (includingduplication mutations) who are treated with poziotinib:Primary Objective:Objective Response Rate (ORR)Secondary Objectives:• Disease…