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Pharmacokinetic boosting of osimertinib in patients with non-small cell lung cancer.

The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is enhanced when osimertinib is co-administered with cobicistat in patients with relatively low blood concentrations while receiving the standard…

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…

A performance evaluation study for the testing of DNA extracted from either tumor tissue biopsy samples or plasma, using the therascreen® EGFR Plus RGQ PCR Kit, from subjects with Non-Small Cell Lung Cancer, being screened for inclusion in Taiho Oncology, Inc*s Clinical Trial (Protocol No. 10073010).

For Taiho's Study (drug study):Primary Objectives: • Phase 1 Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose (RP2D) and dosing schedule of TAS3351.• Phase 1 Dose Expansion: To explore the efficacy of…

Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates (AB1MALTISC)

The overall purpose of this study is to characterise the clinical safety and performance of the AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation…

A Phase 2 Randomized Study of Relatlimab plus Nivolumab in
Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

This study has been transitioned to CTIS with ID 2023-508372-10-00 check the CTIS register for the current data. Part 1: dose safety confirmationPrimary: To evaluate the proportion of participants with TRAEs leading to discontinuation within 12…

A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Participants with Advanced or Metastatic Solid Tumors

This study has been transitioned to CTIS with ID 2022-502774-17-00 check the CTIS register for the current data. Part A Dose Escalation: To assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and determine the…

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 III, OPEN-LABEL, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD L1 ANTIBODY) COMPARED WITH BEST SUPPORTIVE CARE FOLLOWING ADJUVANT CISPLATIN BASED CHEMOTHERAPY IN PATIENTS WITH COMPLETELY RESECTED STAGE IB-IIIA NON-SMALL CELL LUNG CANCER.

This study has been transitioned to CTIS with ID 2023-505981-26-00 check the CTIS register for the current data. Primary Efficacy ObjectiveThe primary efficacy objective of the study is as follows:• To evaluate the efficacy of 16 cycles of…

Immunological effects of stereotactic radiotherapy - An exploratory trial (iDOSE)

Objective: To identify immunological responses elicited by different schedules of SABR in ES-NSCLC. Expression rates and activation states of immune effector subsets will be assessed in peripheral blood and liquid biopsies (plasma/serum).Hypothesis…

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).…

A Phase 3, Randomized, Double blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer

This study has been transitioned to CTIS with ID 2022-502658-15-00 check the CTIS register for the current data. Primary Objective• To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A (vs Arm B…

A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients with
BRAFV600-mutant Non-small Cell Lung Cancer

Primary Objective:To evaluate the efficacy of encorafenib + binimetinib in treatment-naïve and previously treated patients with BRAFV600E-mutant NSCLC as measured by ORR.Secondary objectives:1. To evaluate the efficacy of encorafenib + binimetinib…

A Phase 3, randomized, open label study of lorlatinib (PF 06463922) monotherapy versus crizotinib monotherapy in the first line treatment of patients with advanced ALK positive non small cell lung cancer

This study has been transitioned to CTIS with ID 2023-509169-19-00 check the CTIS register for the current data. To demonstrate that lorlatinib as a single agent (Arm A) is superior to crizotinib alone (Arm B) in prolonging Progression-Free Survival…

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, multicenter, study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type (wt), advanced nonsmall cell lung cancer (NSCLC) (CINC280A2201)

Primary: To evaluate the antitumor activity of INC280, as measured by overall response rate (ORR) as by a blinded independent review committee, by cohort.Secondary: Duration of response (DOR), ORR and DOR by investigator, time to response (TTR),…

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…

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…

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.