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An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (bintrafusp alfa) versus Pembrolizumab as a First-line Treatment in Patients with PD-L1 Expressing Advanced Non-small Cell Lung Cancer (MS200647-0037)

To demontrate improvement of progression-free survival (PFS) and/or overall survival (OS) with M7824 compared with pembrolizumab in first-line participants with advanced NSCLC with high PD-L1 tumor expression.

A Phase II Trial of Personalized Tumor Neoantigen Based Vaccine FRAME-001 for Advanced Non-Small Cell Lung Cancer

To determine FRAME-001-specific immune responses in peripheral blood after administration of FRAME-001 to patients with advanced NSCLC.Secondary objectives- To assess safety and tolerability of FRAME-001.- To evaluate clinical anti-tumor response to…

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus platinum doublet chemotherapy versus platinum doublet chemotherapy in Subjects with Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

The study will look at patients with chemotherapy-naive Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC). The research aims to compare a new drug called nivolumab OR nivolumab with ipilimumab (another cancer drug) OR nivolumab combined with…

A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of canakinumab in combination with docetaxel versus placebo in combination with docetaxel in subjects with non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy (CACZ885V2301, CANOPY-2)

Primary: Safety run-in part (part 1):* to confirm tthe recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with docetaxel. Double-blind, randomized, placebo-controlled part (part 2):* to compare the overall survival (OS) between…

An Open-label Single-arm Pharmacokinetic Trial, Investigating the Effect of CYP3A4 inhibitor Ritonavir on the Pharmacokinetics of Erlotinib

Primary: 1. Effect of the highly potent CYP3A4 inhibitor ritonavir on the pharmacokinetics (PK) of erlotinib, measured as AUC0-24h, AUCmean, Cmax and CminSecondary objective 1. Safety of the CYP3A4 moderator ritonavir in combination with erlotinib,…

Continuous and Bi-level positive airway pressure for motion mitigation of intra-thoracic tumors treated with radiotherapy

The main objective of this pilot study is to evaluate the effect of motion mitigation with BiPAP or CPAP on tumor motion during the course of radiotherapy in patients with intra-thoracic tumors.

Erector Spinae Plane Block versus Thoracic Epidural Block in Elective Video-Assisted Thoracic Surgery (VATS): A Prospective Randomized Open Label non-inferiority Trial

Evaluate the non-inferiority of the ESP-block compared to the TEA in VATS lobectomy or wedge resection.

Combining SBRT and pembrolizumab in early stage non-small cell lungcancer patients planned for surgery: exploring safety and immunological proof of principle.

To identify the immunological response to combined SABR and pembrolizumab treatment in early stage NSCLC. Expression rates andactivation states of immune effector subsets will be assessed in tumor core biopsy specimens, peripheral blood and tumor…

A randomized, open-label, phase II study of canakinumab or pembrolizumab as monotherapy or in combination as neoadjuvant therapy in subjects with resectable non-small cell lung cancer (CANOPY-N)

Primary: • To assess the Major Pathological Response (MPR) rate (<= 10% of residual viable tumor cells) on the resected specimen at the time of surgery in all subjects randomized to canakinumab alone or in combination with pembrolizumab.…

Activity of Lorlatinib based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with 2nd generation ALK inhibitor

To assess the progression-free survival rate at 12 months (PFSR12) to lorlatinib in ALK positive advanced NSCLC patients, who progressed on second generation ALK-TKI with the presence of ALK resistance mutations on blood (liquid biopsies) by…

A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

This study has been transitioned to CTIS with ID 2023-508214-42-00 check the CTIS register for the current data. Primary: To compare the efficacy of AMG 510 versus docetaxel as assessed by progression-free survival (PFS) in previously treated…

A single arm phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC

The primary objective is to assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST v1.1. The secondary objectives are to evaluate secondary measures of clinical efficacy including disease control, progression-free…

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 II, multi-center, open-label, five-arm study to evaluate the efficacy and safety of oral ceritinib treatment for patients with ALK-positive non-small cell lung cancer (NSCLC) metastatic to the brain and/or to leptomeninges.

The primary objective is to evaluate the antitumor activity of ceritinib in patients with ALK-positive NSCLC metastatic to the brain and/or toleptomeninges based on whole body overall response rate (ORR), defined as the proportion of patients with a…

A Phase III, Open-label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination with Tremelimumab, Determined by PD-L1 Expression, Versus Standard of Care in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB IV) who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC)

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…

Phase I Study: safety and immunogenicity of vaccination with XAGE1B long peptides combined with
poly-ICLC in patients with pulmonary adenocarcinoma

Primary objective:* To evaluate the safety of vaccination with XAGE1B peptides emulsified in Montanide ISA 51 co-mixed with the adjuvant Hiltonol® (Poly-ICLC) in patients with pulmonary adenocarcinoma.Secondary objective* To evaluate the capacity of…

A Phase I, Open-label, Non-randomised Study to Assess the Effect of
Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral
Dose of AZD9291 in Patients with EGFRm Positive NSCLC Whose Disease
has Progressed on an EGFR TKI

To investigate the effect of a CYP3A4 inhibitor (itraconazole) on the PK of AZD9291.

A randomized phase III study of monotherapy docetaxel or intercalated erlotinib docetaxel combination therapy in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma. (NVALT 18 study)

The objective of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.

Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients

Primary: Dose confirmation part: To establish the Maximum Tolerated Dose (MTD) and/or Recommended dose for expansion (RDE) of PDR001 with platinum-doublet chemotherapy in treatment naïve patients with PD-L1 unselected, advanced NSCLC of squamous or…

A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo as Maintenance Therapy in Subjects with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) after Completion of Platinum-based First Line Chemotherapy

The aim of the study is to compare overall survival (OS) and Blinded Independent Central Review (BICR)-assessed progression free survival (PFS), of nivolumab, and nivolumab in combination with ipilimumab, versus placebo in subjects with ED-SCLC…