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platinum-based chemotherapy with or without Sintilimab

Participants received oral PLB1004 240mg on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 5 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive oral PLB1004 240mg and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.

PLB1004

Participants received IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 5 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Sintilimab 200mg intravenously administered on day 1 q3w per investigator's decision. Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive oral PLB1004 and 500 mg/m\^2 of pemetrexed on Day 1 q3w and Sintilimab 200mg intravenously administered on day 1 q3w per investigator's decision. until disease progression in the maintenance period.

Pemetrexed+（carboplatin or Cisplatin）with or without Sintilimab

Weizhe Xue

Efficacy and safety evaluation of PLB1004 in patients with locally advanced/metastatic non-squamous NSCLCharboring EGFR exon 20 insertion.

Randomized, controlled, open label, multicenter phase III study to evaluate the efficacy and safety of PLB1004 Versus platinum-based chemotherapy with or without Sintilimab in the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) Exon 20 insertion(ex 20) mutations.

Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.

Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of PLB1004 Versus Platinum-based Chemotherapy With or Without Sintilimab of Advanced NSCLC With EGFR Exon 20 Ins Mutations

Reference RECIST v1.1, intracranial PFS assessed by BICR and investigator

Investigator-assessed second progression-free survival (PFS2)

Use the EQ-5D-5L scale to measure patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.

EGFR Ex20ins status in tumor tissues and its relevance to the clinical efficacy of drugs

To assess the expression of circulating tumor DNA in ascites and blood, ctDNA was mesured at screen, cycle 3 and end of the study

Progression-free survival (PFS) as assessed by a Blind Independent Center Review Committee (BICR) with reference to RECIST v1.1 for Solid tumors

Refer to RECIST v1.1, PFS assessed by the investigator

To evaluate the intracranial Overall Response Rate（ORR）which is defined by investigator as the proportion of subjects with Intracranial disease confirmed best overall response of complete response or partial response per RECIST v 1.1.

DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first.

DCR is defined as the percentage of participants achieving complete or partial response or stable disease as defined per RECIST v 1.1

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

A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug assessed by CTCAE v5.0

Plasma concentrations of PLB1004 and metabolites may be combined with data from other clinical studies

Avistone Biotechnology Co., Ltd.

PLB1004 is a capsule in the form of 10mg and 40mg.

Yilong Wu, MD

This is a phase I, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PLB1004, and to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D).

The study includes a Dose-escalation Part and a Dose Expansion Part. The aim of the Dose-escalation Part is to estimate the MTD (if possible), identify the DLT (if possible) and the RP2D for PLB1004. The Dose Expansion Part is to further assess the clinical efficacy and safety of PLB1004.

Assessing the Safety and Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase I, Open-label, Multicenter, Dose Escalation and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Toxicity will be evaluated according to the NCI CTCAE, Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.

The MTD is the highest dose level at which the participant tolerates treatment without dose-limiting toxicities.

The RP2D is the maximum tolerated dose (MTD) or less. An RP2D less than the MTD may be chosen if aspects of tolerability or efficacy not encompassed by the MTD determination suggest utilizing a lower dose.

The AUC values are based on the plasma concentration-time profile of PLB1004. To characterize the pharmacokinetics of PLB1004.

The Cmax values are based on the plasma concentration-time profile of PLB1004. To characterize the pharmacokinetics of PLB1004.

The Tmax values are based on the plasma concentration-time profile of PLB1004. To characterize the pharmacokinetics of PLB1004.

ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.

PFS is defined as the time interval from the date of starting treatment until the first date at which the criteria for progressive disease (PD) according to RECIST 1.1 are met or death, whichever occurs first.

OS is defined as the time from date of starting treatment to date of death due to any cause.

DCR is defined as the percentage of participants who have achieved CR, PR, or SD after the initiation of study drug.

DOR is defined as the time from first documented response of CR or PR to date of first documented progression or death according to RECIST 1.1.

In the dose-escalation and dose-expansion phase, patients received oral Vebreltinib 100mg/150mg/200mg BID plus PLB1004 80mg/160mg once daily.

In phase II-Cohort 1:Failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）.

In phase II-Cohort 2 :Failed third-generation EGFR inhibitors, c-Met amplification(GCN≥6).Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）.

In phase II-Cohort 3 :Failed first-generation or second-generation EGFR inhibitors, c-Met over expression.Patients received oral Vebreltinib（RP2D）plus PLB1004 （RP2D）.

Phase Ib is a dose escalation study, the initial dose of Vebreltinib is 100mg/150mg/200mg,according to the result of Phase Ib, will confirm the RP2D.

Vebreltinib

Phase Ib is a dose escalation study, the initial dose of PLB1004 is 80mg/160mg,according to the result of Phase Ib, will confirm the RP2D.

Liang Lin

Caichun Zhou, PHD

Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC

Open label, multicenter Phase Ib/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of Vebreltinib in combination with PLB1004 in patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or MET amplification following EGFR-TKI treatment failure.

Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI

A Phase Ib/II Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI

In phase Ib，Incidence of Treatment-Emergent Adverse Events (TEAEs),

In phase Ib，Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol

In phase II,ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.

In phase Ib，Measurement of PK parameters: Area under the concentration time curve (AUC)

In phase Ib，Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)

In phase Ib，Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)

In phase II，Incidence of Treatment-Emergent Adverse Events (TEAEs),A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

PLB1004 is a capsule in the form of 80mg and 40mg.

Jinji Yang, MD

It is a phase Ⅱ,open-label, single-line, Multiple cohorts, Multicenter study assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins mutation patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC).

This a three-stage study consist a Screening Phase (Day -28 to -1), a Treatment Phase (until treatment discontinuation), and a Follow-up Phase (including end of treatment visit (EOT),end of study visit(EOS), safety follow-up and survival follow-up).

A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)

A Phase Ⅱ,Open-label, Single-line, Multiple Cohorts, Multicenter Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)

To evaluate the Objective Response Rate（ORR）which is defined by IRC as the proportion of subjects with confirmed best overall response of complete response or partial response per RECIST v 1.1.

To evaluate the Overall Response Rate（ORR）which is defined by investigator as the proportion of subjects with confirmed best overall response of complete response or partial response per RECIST v 1.1.

DCR is defined as the percentage of participants achieving complete or partial response or stable disease of at least 11 weeks as defined per RECIST v 1.1

PFS is defined as the time from the date the first dose until the date of objective disease progression or death by cause, whichever comes first, based on investigator review according to RECISTv1.1.

Intracranial DCR is defined as the percentage of participants achieving Intracranial disease complete or partial response or stable disease of at least 11 weeks as defined per RECIST v 1.1.

Intracranial DOR is defined as the time from the date of first documented response (CR or PR) until the date of Intracranial disease documented progression or death, whichever comes first.

Intracranial PFS is defined as the time from the date the first dose until the date of objective disease progression or death by cause, whichever comes first, based on investigator review according to RECISTv1.1.

A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug assessed by CTCAE v5.0.

Number of participants with abnormalities in Clinical Laboratory tests（including serum chemistry and hematology） will be reported.

Number of participants with abnormalities in vital signs(including temperature ,pulse/heart rate，and blood pressure) will be reported.

The AUC values are based on the plasma concentration-time profile (from time 0 to Time of the Last Quantifiable Concentration) of PLB1004. To characterize the pharmacokinetics of PLB1004.

The AUC values are based on the plasma concentration-time profile (from time 0 to infinity) of PLB1004. To characterize the pharmacokinetics of PLB1004.

The Tmax values are based on the plasma concentration-time profile of PLB 1004.To characterize the pharmacokinetics of PLB1004.

The t1/2 values are based on the terminal disposition Phase Half-life for PLB1004 and its Active Metabolites. To characterize the pharmacokinetics of PLB1004.

The CL/F values are based on the apparent clearance after extravascular administration for PLB1004. To characterize the pharmacokinetics of PLB1004.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.	NCT06281964	Non-Small-Cell ...	PLB1004 Pemetrexed+（car...	18 Years -	Avistone Biotechnology Co., Ltd.
Assessing the Safety and Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)	NCT05347628	Non-Small-Cell ...	PLB1004	18 Years -	Avistone Biotechnology Co., Ltd.
Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI	NCT06343064	Non-Small-Cell ...	Vebreltinib PLB1004	18 Years -	Avistone Biotechnology Co., Ltd.
Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.	NCT06281964	Non-Small-Cell ...	PLB1004 Pemetrexed+（car...	18 Years -	Avistone Biotechnology Co., Ltd.
Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI	NCT06343064	Non-Small-Cell ...	Vebreltinib PLB1004	18 Years -	Avistone Biotechnology Co., Ltd.
A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)	NCT06015503	Non-Small-Cell ...	PLB1004	18 Years -	Avistone Biotechnology Co., Ltd.

Spots Global Cancer Trial Database for plb1004

Every month we try and update this database with for plb1004 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for plb1004

Every month we try and update this database with for plb1004 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for plb1004 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.