Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma...
Lung CancerNon-small Cell Lung CancerThis clinical trial is an open-label, single arm study evaluating the safest dose of lorlatinib in combination with standard of care chemotherapy in participants with metastatic anaplastic lymphoma kinase positive (ALK+) NSCLC who progressed on prior therapy of lorlatinib alone. The main goals of this study are to: Evaluate the safety and tolerability of lorlatinib in combination with standard of care chemotherapy. Evaluate how well the combination of lorlatinib and standard of care chemotherapy works to treat metastatic anaplastic lymphoma kinase positive (ALK+) NSCLC. Evaluate the pharmacokinetics (PK) of lorlatinib when given in combination with standard of care chemotherapy.
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
CancerCancer1 moreThe goal of this clinical trial is to test CPO301, a type of drug called an antibody drug conjugate in adult patients with advanced or metastatic solid tumors. The main questions it aims to answer are: To assess the safety and tolerability of CPO301 at increasing doses and determine the dose to be used in the second part of the study (Part A) To assess the safety and tolerability of CPO301 at the dose determined to be safe and tolerable in Part A in patients with Non-Small Cell Lung Cancer and potentially other tumor types (Part B) To evaluate how quickly CPO301 is metabolized by the body (pharmacokinetics or PK) To evaluate if antibodies to the study drug develop (immunogenicity) To evaluate preliminary efficacy to the drug To correlate preliminary efficacy with mutations in a biomarker called EGFR Participants will: Provide written informed consent Undergo screening tests to ensure they are eligible for study treatment Attend all required study visits and receive CPO301 by intravenous injection every 3 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment Be followed for progression every 3 months for up to 2 years
The Effects of an Nutritional Intervention on PD-1 ICI in NSCLC
Non-small Cell Lung CancerOver 65% of all lung cancer patients experience significant weight loss fuelled by a catabolic state that is represented by enhanced protein breakdown. The metabolic state of patients is a key effector of protein clearance, and the increased albumin as well as monoclonal antibodies clearance that is observed in patients with progressive cancer disease inversely correlates with treatment response and may well be consequential to changes in the metabolic state of cancer patients. Interestingly, several studies in cancer patients receiving chemotherapy, amongst which are NSCLC patients, have shown that weight loss and catabolism can be prevented or improved by intake of high energy/high protein Oral Nutritional Supplements (ONS). An increased clearance of anti-PD-1 ICI may also represent a general dysfunctioning of the immune system, because immune cell activation, proliferation, migration and tumor cell killing may all be influenced by cachexia. Enrichment of nutritional supplements with specific nutrients known to have immune-modulating properties, may further balance immune responses supportive of ICI efficacy. The investigators hypothesize that high energy/high protein nutritional supplements decrease protein clearance including drug clearance in NSCLC patients receiving anti-PD-1 ICIs, which on its turn would positively affect anti-PD-1 drug bioavailability, leading to activation of the immune system and thereby an increased response to PD-1 ICIs. The primary aim is to investigate the variability of clearance during a 12-weeks nutritional intervention period. The secondary aim is to investigate the feasibility for the subjects to comply with the study protocol. Lastly, the investigators aim to study the feasibility of gathering data on a number of exploratory parameters that may link nutritional intake to clinically relevant outcomes.
AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
Advanced Non-small-cell Lung CancerThis trial is a Phase Ib/II study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and AK104 with or without chemothorapy in subjects with advanced NSCLC.
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced...
Locally AdvancedNon-small Cell Lung CancerFor unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.
Efficacy and Safety of PVT-1 Treatment in Patients With Advanced Non-Small Cell Lung Cancer
Non Small Cell Lung CancerAdvanced Cancer1 moreLung cancer is one of the most common causes of cancer death worldwide. It is projected that the vast majority, approximately 80% -85% of all lung cancer diagnosis is Non-Small Cell Lung Cancer (NSCLC). Although there are significant improvements in the treatment of Lung Cancer in recent years, there is still an unmet medical need for a specific population which has advanced NSCLC and mostly is refractory to existing treatments. In NSCLC the molecular profile is important to direct the treatment. Specifically, for cases with an EGFR+, ALK+, ROS1+ or PD1/PDL1+ molecular profile, targeted treatments are available. PVT-1 is a safe, orally administrable and well-tolerated drug directed against a specific therapeutic target of cancer cells what has demonstrated efficacy in NSCLC with a molecular profile EGFR-, ALK-, ROS1- and refractory to anti-PD1 / PDL1, in last line, which also represents the highest percentage of patients and with the highest chances of cancer progression with currently available treatments.
Keynatinib in Treated Patients With NSCLC and Brain Metastases
Non-Small Cell Lung Cancer With EGFR MutationBrain MetastasesThe purpose of this study is to evaluate the safety and efficacy of Keynatinib capsules in patients with advanced non-small cell lung cancer (NSCLC) with brain metastasis or progression of brain metastasis after treatment with EGFR inhibitors. As well as, to evaluate the penetration rate of Keynatinib in the Blood-Brain Barrier (BBB) and its PK characteristics, and the relationship between exposure levels with efficacy and safety.
Study of ZKAB001 Combined With Carboplatin and Etoposide in the Extensive Small Cell Lung Cancer...
Extensive Stage Small Cell Lung CancerTo evaluate the safety and efficacy of recombinant anti-PD-L1 monoclonal antibody injection (ZKAB001) combined with carboplatin and etoposide in the treatment of extensive-stage small cell lung cancer.
Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer
Loco-regionally Recurrent NSCLC After Thoracic RadiotherapyThis prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.
Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients...
Non-small Cell Lung Cancer MetastaticTreating Non-small Cell Lung Cancer (NSCLC) Patients with MET exon 14mutations with Savolitinib