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NSCLC clinical trials

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NCT ID: NCT03318939 Terminated - NSCLC Clinical Trials

Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

Start date: October 13, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).

NCT ID: NCT03301688 Completed - NSCLC Clinical Trials

The Pharmacokinetics and Safety of Single-dose and Parallel Comparisons in Patients With NSCLC Treated With JS001

Start date: September 18, 2017
Phase: Phase 1
Study type: Interventional

This study was designed to evaluate the similarity of single-dose and parallel comparisons of recombinant humanized anti-PD-1 monoclonal antibody injections before and after process changes. It is designed to be a single-center, open and parallel controlled phase I study. Patients with advanced NSCLC will be enrolled. After determining that the patient is qualified, the patient will be assigned to a batch of drug use in the order in which they are selected. The dosage of drug was set at 3 mg / kg. Planned to recruit subjects each 12 patients (24 cases) to participate in this study, taking into account a 20% dropout rate, so that the total of 15 patients (30 patients) subjects in each group in this study. This study was divided into study phase (single-dose period) and follow-up stage (multiple-dose period).Each subject first conducted a single dose safety and pharmacokinetics (PK) study.If the subject did not develop adverse events that had significant clinical significance as suggested by the investigators within 28 days of the single dose and continued reorganization of the humanized anti-PD-1 monoclonal antibody injection to benefit the patient , and with the agreement of subjects, the subject will enter the follow-up phase (multiple-dose period). The same dose of recombinant humanized anti-PD-1 monoclonal antibody injection was administered once every 2 weeks and 4 consecutive cycles of treatment for one cycle of continuous period.Until the patient has developed tumor progression or an untolerated toxic side effect, the patient voluntarily exits the study or believes that the situation is not suitable for continuing treatment. There are follow-up of 90 days after treatment.

NCT ID: NCT03269162 Active, not recruiting - NSCLC Clinical Trials

Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection

Start date: September 30, 2016
Phase: Phase 3
Study type: Interventional

Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group, N=72). Peripheral blood CTCs and immune cells were detect on five different time points: after operation、4 chemotherapy cycles were over、12 months after operation、18 months after operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life of postoperative patients; and decreasing the side effect of chemotherapy.

NCT ID: NCT03265496 Terminated - Nsclc Clinical Trials

Correlation Between Tissue and Plasmatic EGFR in CBNPC With EGFR Mutation or Predictive Factor of EGFR Mutation

CONCORDE
Start date: July 7, 2016
Phase: N/A
Study type: Interventional

Condorde main objective is to evaluate the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed on ctDNA after liquid biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.

NCT ID: NCT03256981 Active, not recruiting - NSCLC Clinical Trials

Stereotactic Body Radiotherapy for the Treatment of OPD

HALT
Start date: November 27, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

HALT is a phase II, randomised multi-centre study with integrated seamless continuation to phase III trial following acceptable safety and feasibility assessment. HALT aims to recruit 110 patients with mutation positive advanced NSCLC with oligoprogressive disease (OPD) following initial response to a Tyrosine Kinase Inhibitor (TKI).

NCT ID: NCT03246854 Terminated - Clinical trials for Head and Neck Cancer

A Study of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer

Start date: July 18, 2017
Phase: Phase 1
Study type: Interventional

The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR mutated lung cancer.

NCT ID: NCT03175224 Recruiting - Lung Cancer Clinical Trials

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

SPARTA
Start date: September 27, 2017
Phase: Phase 2
Study type: Interventional

To assess: - efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET - efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I)

NCT ID: NCT03166254 Withdrawn - Clinical trials for Non-small Cell Lung Cancer

Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab and Standard of Care Chemotherapy in Squamous Non-Small Cell Lung Cancer and Extensive Stage Small Cell Lung Cancer

Start date: April 30, 2019
Phase: Phase 1
Study type: Interventional

Both metastatic squamous non-small cell lung cancer (NSCLC) and extensive stage small cell lung cancer (SCLC) are incurable with current therapies, but due to mutations induced by cigarette smoke, typically express a large number of altered proteins that can be recognized as foreign by the immune system. This antigenicity is thought to explain the efficacy of pembrolizumab as either a first or second line treatment in this disease. For patients who receive chemotherapy plus immunotherapy as a first line therapy, there is sound rationale for combination treatment with immunotherapy and a therapeutic antitumor vaccine as a maintenance strategy. Regardless of PD-L1 expression in the tumor, monoclonal antibodies that block PD-1/PD-L1 interactions are effective second line therapies after chemotherapy in both NSCLC and SCLC. In addition, by targeting the immune system against tumor specific antigens using a peptide vaccine, the efficacy of pembrolizumab alone is expected to be enhanced, with an improved response rate and prolonged overall survival with no additional toxicity. This pilot study will provide a preliminary test of the feasibility of generating a personalized, tumor neoantigen-specific therapeutic vaccine and the safety of combining it with checkpoint blockade immunotherapy.

NCT ID: NCT03164772 Completed - NSCLC Clinical Trials

Phase 1/2 Study of Combination Immunotherapy and Messenger Ribonucleic Acid (mRNA) Vaccine in Subjects With NSCLC

Start date: December 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicenter, 2-arm study to evaluate the safety and preliminary efficacy of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC. Arm A: messenger ribonucleic acid (mRNA) Vaccine [BI 1361849 (formerly CV9202)] + anti-programmed death ligand 1 (PD-L1) antibody [durvalumab] Arm B: messenger ribonucleic acid (mRNA) Vaccine [BI 1361849] + anti-programmed death ligand 1 (PD-L1) [durvalumab] + anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody [tremelimumab] The run-in evaluation phase is followed by an expansion phase in which the cohort is expanded to 20 subjects (inclusive of subjects from the run-in).

NCT ID: NCT03073902 Completed - NSCLC Clinical Trials

The Correlation of PD-L1 Expression in Non-small Lung Cancer Tissue and Peripheral Blood T Cell and Serum.

Start date: March 25, 2017
Phase:
Study type: Observational

The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 expression in serum and peripheral blood T cell are expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum..The investigators have designed to detected the expression levels of PD-L1 protein in cancer tissue and detected the expression levels of PD-L1 in peripheral blood T cell and serum.By using variance analysis of repeated measures design information. Thus exploring the correlation of PD-L1 expression in non-small lung cancer tissue and peripheral blood T cell and serum,guiding clinical practice of immunotherapy.