Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Dose escalation: 6 dose levels The dose escalation study is proposed to include 6 dose levels: 30, 90, 180, 270, 360, and 480 mg once daily.

(It can be adjusted based on clinical PK data and safety results after discussion between PI and the sponsor).

Dose-expansion: After the initial data evaluation, the Sponsor and the SMC will select 2-3 dose levels to evaluate drug safety and PK further, explore its preliminary efficacy, and determine RP2D.

Efficacy expansion: The RP2D determined in dose escalation and dose expansion will be applied.

WJ13404 tablets

Yongdong Zhang

Banyu Zhang

This is an open-label phase I/II preliminary study, including dose escalation, dose expansion, and efficacy expansion, to evaluate drug safety, tolerability, PK, and efficacy. The dose escalation study evaluates the IMP's safety, tolerability, and PK in patients with locally advanced or metastatic NSCLC who have experienced disease progression after third-generation EGFR-TKI therapy. The dose expansion study, after 2-3 dose levels are selected based on dose escalation results, further investigates the IMP's safety, tolerability, and PK, explores preliminary efficacy, and determines RP2D in patients with locally advanced or metastatic NSCLC harboring EGFR C797X mutation. The efficacy expansion study evaluates the IMP's safety and efficacy in patients with locally advanced or metastatic NSCLC harboring EGFR C797X mutation.

A Phase I/II Study of WJ13404 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WJ13405 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer

To evaluate incidence，severity and outcome of adverse events（AE),and serious adverse events（SAE)

Proportion of patients who have the best response of confirmed or partial response as per RECIST v1.1.ORR, along with its 95% CI, will be calculated

DLT is defined as any of the following toxicities that occur during the DLT observation and are deemed by investigators possibly, probably, or definitely related to WJ13404 as per NCI-CTCAE v5.0

It's suitable for dose escaltion and does extension ,maximum plasmaconcentration

It's suitable for dose escaltion and does extension,time to Cmax

It's suitable for dose escaltion and does extension,area under the concentration versus time curve from time 0 to the last measurable concentration.

It's suitable for dose escaltion and does extension, elimination half-life.

It's suitable for dose escaltion and does extension, clearance.

It's suitable for dose escaltion and does extensionapparent volume of distribution

It's suitable for dose escaltion and does extension, elimination rate constant.

It's suitable for dose escaltion and does extension,minimum concentration at steady state.

It's suitable for dose escaltion and does extension,maximum concentration at steady state.

It's suitable for dose escaltion and does extension, average concentration at steady state.

It's suitable for dose escaltion and does extension,area under the concentration versus time curve for a dosing interval at steady state.

It's suitable for dose escaltion and does extension,volume of distribution at steady state.

It's suitable for dose escaltion and does extension,accumulation ratio.

It's suitable for dose escaltion and does extension,degree of fluctuation.

It's suitable for dose escaltion and does extension, objective response rate.

It's suitable for dose escaltion and does extension, duration of response.

It's suitable for dose escaltion and does extension, disease control rate.

It's suitable for dose escaltion and does extension, progression-free survival.

It's suitable for dose escaltion and does extension,overall survival.

Sponsor GmbH

Suzhou Junjing BioSciences Co., Ltd.

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

ASK120067 (80 mg orally, twice daily) plus placebo Gefitinib (250 mg orally, once daily), in accordance with the randomization schedule.

Gefitinib (250 mg orally, once daily) plus placebo ASK120067 (80 mg orally, twice daily), in accordance with the randomization schedule.

ASK120067 (80 mg orally twice daily) . A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

ASK120067

The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

Placebo Gefitinib 250 mg

Gefitinib (250 mg orally, once daily) , A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit acording to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

Placebo ASK120067orally 80mg twice daily . A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

Placebo ASK120067

Tingting Song

Luwei Han

Yuankai Shi

Baolan Li

Jifeng Feng

To assess the efficacy and safety of ASK120067 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor Gefitinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

Triple (Participant, Investigator, Outcomes Assessor)

ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC

A Phase III,Double-Blind, Randomised Study to Assess the Efficacy and Safety of ASK120067 Versus Gefitinib as First-Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy prior to progression and was used to assess the efficacy of single agent ASK120067 compared with Gefitinib as measured by PFS.

ORR was defined as the number (%) of patients with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of ASK120067 compared with Gefitinib defined as the number (%) of patients with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of ASK120067 compared with Gefitinib

Duration of response was defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression and was used to further assess the efficacy of ASK120067 compared with Gefitinib

The DCR was defined as the percentage of participants who had a best overall response (BOR) of Complete response (CR), Partial response (PR) or Stable disease (SD) ≥6 weeks prior to any Progressive disease (PD) event and was used to further assess the efficacy of ASK120067 compared with Gefitinib

The Depth of response was defined as the relative change in the sum of the longest diameters of Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions (TLs) at the nadir, in the absence of new lesions (NLs) or progression of Non-target lesions

Overall survival was defined as the time from the date of randomisation until death from any cause and was used to further assess the efficacy of ASK120067 compared with Gefitinib

Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Patients with confirmed EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed from first line EGFR-TKI therapy who will receive different treatment

Weimin Li, Doctor

To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.

The objectives of this study are to assess molecular testing, treatment patterns, and associated clinical outcomes among patients with epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed from first-line EGFR-TKI (tyrosine kinase inhibitor) therapy. This study is descriptive in nature and does not attempt to test any specific a priori hypotheses

Real World Study in Locally Advanced or Metastatic NSCLC Patients, Progressed From First-line EGFR-TKI Therapy

Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in EGFR Mutation-Positive, Locally Advanced or Metastatic Chinese NSCLC Patients, Who Have Progressed From First-line EGFR-TKI Therapy (PISCES)

Chinese laws and regulations do not allow.

from date of second-line treatment initiation until progression by RECIST1.1 criteria, or death

the date of second-line treatment initiation until death from any cause(only for patients receiving 2L CT and 2L TKI, separately)

Time to initiate second line therapy from RECIST1.1 defined progression from 1L treatment

Response rate reported by physician or judged by Recist1.1 after receiving any pattern of therapy

For each line of chemotherapy received but not limited in:Therapy regimen，Therapy duration measured as time from therapy start date to time of therapy end date，Number of cycles received，Reason for cessation of therapy

For each line of immunotherapy received but not limited in:Therapy regimen，Therapy duration measured as time from therapy start date to time of therapy end date，Number of cycles received，Reason for cessation of therapy

For each line of targeted therapy received but not limited in:Therapy regimen，Therapy duration measured as time from therapy start date to time of therapy end date，Number of cycles received，Reason for cessation of therapy

For each line of local therapy received but not limited in:Therapy regimen，Therapy duration measured as time from therapy start date to time of therapy end date，Number of cycles received，Reason for cessation of therapy

To estimate parameters in the target population associated with molecular testing patterns, including molecular testing sample type

To estimate parameters in the target population associated with molecular testing patterns, including molecular test outcome

To estimate parameters associated with molecular testing patterns, including changes in testing rate over time

Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients

Time from the RECIST defined progression date to molecular testing

To estimate parameters in the target population associated with molecular testing patterns, including molecular testing method of biopsy

To estimate parameters in the target population associated with molecular testing patterns, including molecular testing turnaround time

To estimate parameters in the target population associated with molecular testing patterns, including molecular test type

To estimate parameters in the target population associated with molecular testing patterns, including reason for molecular testing

To estimate parameters in the target population associated with molecular testing patterns, including molecular testing laboratory type

To estimate parameters in the target population associated with molecular testing patterns including reason for not performing a molecular test

To estimate parameters in the target population associated with molecular testing patterns including molecular testing result of mutation status

To estimate parameters in the target population associated with molecular testing patterns, including molecular result of mutation type

To estimate parameters in the target population associated with molecular testing patterns, including histologic/phenotypic transformation

Overall CNS metastases rate, defined as the number of patients developing CNS metastases divided by the number of evaluable patients (From start of 2L therapy)

Brain metastases rate, defined as the number of patients developing brain metastases divided by the number of evaluable patients

Leptomeningeal metastases rate, defined as the number of patients developing leptomeningeal metastases divided by the number of evaluable patients

Treatments for CNS metastases, including type of treatment

Treatments for CNS metastases, including dates of treatment

To assess patient-reported HRQoL using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13)

AstraZeneca

Micronutrients

Hematinics

Vitamins

Paclitaxel

Carboplatin

Pemetrexed

Tislelizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

AK104

carboplatin

Pemetrexed IV, q3w (for Nonsquamous NSCLC)

Zhifang Yao, M.D.

Jie Wang, M.D.

Qingming Wang

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS \< 1%.

A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer (NSCLC)

OS is defined as the time from randomization to death due to any cause.

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1

ORR is the proportion of subjects with CR or PR based on RECIST v1.1

Disease control rate (DCR) was assessed based on RECIST V1.1 criteria

The time from the first administration to the date of documented CR or PR

Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration

Proportion of subjects who develop detectable anti-drug antibodies (ADAs)

EORTC QLQ-C30 measures cancer patients' physical, psychological, and social functions. Scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". Higher score for the functioning scales and global health status denotes a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.

EORTC-QLQ-LC29 measures the quality of life in patients with lung cancer. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". For symptoms scales, higher scores indicated greater symptom burden.

Akeso

patients take ASK120067 orally once per day at different dose

patients take ASK120067 orally once per day at 40,80,160,240,320,480mg

Kai Li

ASK120067 Tablets is a Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant mutation tumor cell in Xenograft mouse model. This study aims at local advanced or metastatic non-small cell lung cancer patients with T790M drug-resistant mutation.

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer

A Phase I/II Study to Assess the Safety,Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Patients With Locally Advanced or Metastatic T790M Mutation-positive Non-Small Cell Lung Cancer Who Have Progressed Following Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent

Evaluation of objective response rate assessed by RECIST 1.1

Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, ophthalmic examinations and NCI CTCAE v4.03

Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival

Duration of response assessed by RECIST 1.1

Evaluation of Disease control rate assessed by RECIST 1.1

defined as the time from date of first dose until date of death due to any cause

Collect plasma concentrations of ASK120067 and 1 metabolites following single dose at designated time points of Day 1 to figure out Cmax

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out tmax

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day1 to figure out AUC

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out terminal rate constant

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out clearance

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out half life

Collect plasma concentrations of f ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out volume of distribution

Collect plasma concentrations of ASK120067 and 1 metabolite following single dose at designated time points of Day 1 to figure out mean resistance time

Cmax of ASK120067 and 1 metabolite at steady state following multiple doses

Tmax of ASK120067 and 1 metabolite at steady state following multiple doses

Cmin of ASK120067 and 1 metabolite at steady state following multiple doses

AUC of ASK120067 and 1 metabolite at steady state following multiple doses

Clearance of ASK120067 and 1 metabolite at steady state following multiple doses

Accumulation ratio of ASK120067 and 1 metabolite following multiple doses

Time dependency of ASK120067 and 1 metabolite following multiple doses

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I/II Study of WJ13404 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer	NCT05662670	Locally Advance...	WJ13404 tablets	18 Years -	Suzhou Junjing BioSciences Co., Ltd.
ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC	NCT04143607	Locally Advance...	ASK120067 Placebo Gefitin... Gefitinib Placebo ASK1200...	18 Years -	Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Real World Study in Locally Advanced or Metastatic NSCLC Patients, Progressed From First-line EGFR-TKI Therapy	NCT04207775	Locally Advance...		18 Years -	AstraZeneca
A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer	NCT05990127	Locally Advance...	AK104 Tislelizumab carboplatin Pemetrexed Paclitaxel	18 Years -	Akeso
A Phase I/II Study of WJ13404 Monotherapy in Patients With Advanced or Mentastatic Non-Small Cell Lung Cancer	NCT05662670	Locally Advance...	WJ13404 tablets	18 Years -	Suzhou Junjing BioSciences Co., Ltd.
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer	NCT03502850	Locally Advance...	ASK120067	18 Years - 75 Years	Jiangsu Aosaikang Pharmaceutical Co., Ltd.
A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer	NCT05990127	Locally Advance...	AK104 Tislelizumab carboplatin Pemetrexed Paclitaxel	18 Years -	Akeso

Spots Global Cancer Trial Database for locally advanced or metastatic nsclc