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53 active trials for Non Small Cell Lung Cancer Metastatic

Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

Crizotinib is a first-generation ALK tyrosine kinase inhibitor (ITK-ALK). It is the standard first-line treatment for patients with advanced NSCLC with ALK gene rearrangement. Alectinib, ceritinib and brigatinib are second-generation ITK-ALK. They have been shown to be effective in the first line of treatment in randomized trials. Alectinib has shown superiority to crizotinib as the first line of treatment in three randomized therapeutic trials, positioning this ITK-ALK as the treatment of choice in first-line treatment. Despite the effectiveness of these new treatments, all patients will virtually experience a relapse. There is no data on second-generation TKI-ALK resistance mechanisms when given as first-line treatment and the best therapeutic strategy for progression is undefined.

Start: August 2020

SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients

Open label multicentric randomized phase II trial, using high throughput genome analysis as a therapeutic decision tool, aimed at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as immunotherapy with maintenance therapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).

Start: April 2014

PD-1 Inhibitors and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer

Overall survival (OS) of patients with advanced (stage IIIB/IV) non-small-cell lung cancer (NSCLC) remains short after the first line of treatment with a median OS of 12.2 months in non squamous NSCLC and 9.2 months in squamous NSCLC . In this setting the programmed death 1/ligand 1 (PD-1/-L1) were targeted with nivolumab (IgG4) in advanced squamous and nonsquamous NSCLC leading to an increase of the 1-year OS rate of approximately 10-15% in both histologies. Nivolumab, pembrolizumab and atezolizumab are now considered a standard of care in 2nd line advanced NSCLC and in 1st line for pembrolizumab but but prognosis still remains poor in advanced NSCLC. Overall survival (OS) of patients with advanced (stage III/IV) NSCLC remains limited with a median OS of 12.2 months in non-squamous NSCLC and 9.2 months in squamous NSCLC if anti-PD1 alone. It is of around 16 months if pembrolizumab is combined with chemotherapy. Preclinical data indicates that anti-tumor efficacy is increased when anti-PD-1/-L1 are combined with irradiation (IR). Radiotherapy alone can elicit tumor cell death which can increase tumor antigen in the blood stream, favoring recognition by the immune system and its activation against tumor cells outside of the radiation field (="abscopal effect"). IR may also reverse acquired resistance to PD-1 blockade immunotherapy by limiting T-cell exhaustion. Because of these preclinical and clinical data several studies analysing the combination of IR and anti-PD1 in NSCLC are ongoing. Among them, two studies are testing the administration of IR and nivolumab in stage III NSCLC: the NCT02768558 phase III trial (RTOG), and the NCT02434081 phase II trial (ETOP). Antonia et al [2017] tested the use of anti-PD-L1 after chemoradiotherapy in unresectable stage III NSCLC. Median time to distant metastasis was increased (23.2 months vs. 14.6 months, p<0.001). An increase of OS is consequently expected. However, no study involving concurrent RT and pembrolizumab combined with chemotherapy in advanced NSCLC is ongoing, which is the purpose of the present study, NIRVANA-Lung.

Start: March 2019

Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M (BOOSTER)

BOOSTER is a randomised, controlled, phase II trial comparing osimertinib and bevacizumab versus osimertinib alone as second-line treatment in patients with stage IIIb-IVb non-small cell lung carcinoma (NSCLC) harbouring activating EGFR (exon 19 deletion or L858R) and T790M resistance mutation.

Start: May 2017

Survival Prolongation by Rationale Innovative Genomics

Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.

Start: November 2017

Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC

This is a Phase II, open label, randomized study of durvalumab in combination with pemetrexed and carboplatin in eligible adult patients with locally advanced or metastatic non-small cell lung cancer. The study will focus on the efficacy of two alternative staggered dosing regimens.

Start: June 2020

Low-dose Gemcitabine Combined With Nivolumab for Second-line and Above Line Treatment of NSCLC

In recent years, immunotherapy research has made great progress, especially the immunocheckpoint inhibitors represented by anti-pd-1 antibody have shown good efficacy in the treatment of malignant tumors, and some patients can achieve long-term survival. However, despite the encouraging clinical data, only a small number of people have benefited. Therefore, how to further improve the efficacy of immunotherapy and expand the benefit population has become the focus of this field. The applicant was previously published in Oncoimmunology (2017; E1331807) pointed out in the above article: MDSC is a group of immunosuppressive cells, the number of this group of cells in the body of cancer patients is more than normal, its presence affects the proliferation, activation and function of T cells, is one of the important factors affecting the efficacy of immunocheckpoint inhibitors. Therefore, ideal drugs used in combination with immunocheckpoint inhibitors should meet the following conditions: first, they can kill or inactivate tumor cells to release tumor-specific or associated antigens; Second, MDSC and other immunosuppressive cells can be eliminated. Third, the number and function of T cells were not affected. Gemcitabine is a synthetic antimetabolic tumor drug widely used in the treatment of locally advanced or metastatic non-small cell lung cancer. Myelosuppression is the dose - limiting toxicity of gemcitabine, which includes lymphocytopenia. Therefore, if the commonly used clinical dose gemcitabine is used in combination with pd-1 antibody, the effect of pd-1 antibody will be affected due to the reduction of lymphocytes caused by gemcitabine. Therefore, we speculated that the reduced-dose treatment of gemcitabine combined with pd-1 antibody might have synergistic anti-tumor effect on the second-line and above second-line treatment of non-small cell lung cancer with negative driver gene, and the adverse reactions were relatively mild. This study is a phase IV, open, non-randomized, single-arm, single-center study to investigate the safety and efficacy of half-dose gemcitabine combined with pd-1 antibody in second-line and above treatment of non-small cell lung cancer patients with negative driver genes. Fifty subjects will be enrolled in this study. The primary endpoint of the study was ORR, while secondary endpoints included DCR, PFS, and OS.

Start: April 2020

Evolution of the Physical Condition in Treated Cancer Patients

Adaptated Physical Activity (APA) during treatment of cancer is one of the actual global health recommendation because of the benefits observed in several parameters evaluated in many clinical studies. A best knowledge of the physical and medical characteristics of patients, including type of cancer and type of treatment, is primordial to optimize the patient care and the effectiveness of APA programs. Descriptive, explorative and prospective study of 3 different populations: One population with locally advanced or metastatic non-small cell lung cancer treated with multiple therapeutic lines. Two different populations of early cancer patients and treated with a platinum-based regimen for colon cancer and a taxane-based chemotherapy for breast cancer.

Start: September 2019

Chemotherapy With Pembrolizumab Continuation After Progression to PD-1/L1 Inhibitors

After progression to previous PD-1/L1 inhibitors (pembrolizumab, nivolumab, or atezolizumab), physicians' choice chemotherapy plus pembolizumab (or placebo) will be administered (3 weeks per cycle) until disease progression or unacceptable toxicity.

Start: November 2018

A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer

The optimal prioritization of second-line chemotherapy and immune therapy based on demographic or biomarker data is an area of ongoing investigation. The hypothesis of this study is that there may be an additive or synergistic antitumor effect of combined chemotherapy and nivolumab in the second-line treatment of NSCLC as an important concept to test in a clinical trial. Previously treated NSCLC remains a setting of unmet clinical need despite recent clinical research progress. Early progression for a subset of NSCLC patients receiving nivolumab is a specific area of clinical need.

Start: December 2016

Exercise Intervention During Chemotherapy in Advanced Lung Cancer Patients

Trial Phase: Pilot Indication: Stage IIIB/IV NSCLC Primary Objective: To assess the feasibility and tolerability of exercise training during palliative chemotherapy. Secondary Objective: 1) To assess fitness levels in patients undergoing palliative chemotherapy, and to explore whether exercise training can prevent a reduction in fitness. 2) To determine the baseline fitness, as assessed by cardiopulmonary exercise testing (CPET), of a cohort of patients with stage IIIb/IV non small cell lung cancer who are about to initiate treatment with chemotherapy 3) To compare patients enrolled in the EMBRACE randomized controlled trial (RCT) with those who decline. 4)To investigate any relationship between baseline fitness and outcomes including therapy related complications, response, and survival in those patients who decline exercise training or are randomized to observation. 5) To assess the feasibility of the translation of in-hospital exercise training to home-based training during chemotherapy. 6) To document the effects of chemotherapy on cellular energetics and mitochondrial function. Rationale: Chemotherapy has a detrimental effect on physical fitness, and this effect can be later reversed by training. The investigators wish to understand the mechanism of this detrimental effect, and investigate whether it can be prevented or attenuated by giving chemotherapy concurrently with exercise training. Trial Design: Randomised controlled study (1:1) comparing chemotherapy alone, with chemotherapy plus exercise training. A subgroup of patients will have muscle biopsies. Patients who decline randomisation will be offered enrolment into an observational arm. Sample size : 100 patients (to include 48 who will be randomised, and 52 in the observational arm).

Start: April 2014

TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC

In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.

Start: January 2019

Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases

With the improvement of systemic therapeutic effect(especially in the population with driver gene mutation), the incidence of brain metastases had significantly increased. Conventional Whole Brain radiotherapy(WBRT) was less effective, the stereotactic radiosurgery(SRS) technique had improve the local efficacy for 1-3 lesions, but the probability of intracranial recurrence was increased, Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost(SIB-IMRT) is a new radiotherapy technology, Giving a standard radiation dose of whole brain ,at the same time can boost the high-risk region in target, So that it can significantly shorten the treatment time, at the same time can improve the local control rate of brain metastases. In the aspect of normal tissue protecting, SIB was better than WBRT plus SRS sequential treatment pattern. 30Gy to the whole brain had a negative effects on cognitive function, the investigators previous study found that 25Gy to the whole brain while the tumor bed Simultaneous push to 50Gy was safe and effective, while reducing the impact on cognitive function. Hippocampus is a part of the brain located in the temporal lobe, Mainly responsible for long-term memory storage conversion and orientation. Many investigators point out that hippocampus is the main commander of neurocognitive function, Reduce the dose of hippocampus can significant improve the neurocognitive function. Temozolomide capsule is an anti-tumor alkylation agent for glioblastoma multiforme and anaplastic astrocytoma. In recent years, some researchers find that Temozolomide capsules combine with radiotherapy such as SRS, WBRT or The two combined, can improve Objective response(OR) and prolong the Progress Free Survival(PFS),while with tolerable therapeutic toxicity. In order to better reduce the impact on cognitive function and improve the local control rate, the investigators present this trial, under the SIB-IMRT technique, the investigators want to explore the effect of temozolomide in brain metastasis of non-small cell lung cancer with the hippocampal protection technology.

Start: March 2019