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Osimertinib

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Tyrosine

Participants receive BL-B01D1 in combination with Osimertinib Mesylate Tablets in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

BL-B01D1

Osimertinib Mesylate Tablets will be administered at a fixed dose of 80mg daily.

Osimertinib Mesylate Tablets

Hai Zhu, PHD

Sa Xiao, PHD

Tao Gui

Caicun Zhou, PHD

A Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 for injection in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer with EGFR-sensitive mutations

Objective: To evaluate the safety, tolerability, and efficacy of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations, and to further explore the optimal dose and mode of combination. Secondary objective: To evaluate the PK, immunogenicity, and drug-drug interaction (DDI) of the investigational drug BL-B01D1. Exploratory objective: To explore potential predictive, prognostic biomarkers in relation to study drug therapy responses, including levels of biomarkers, including but not limited to EGFR, HER3, etc., in archived and/or fresh tumor tissue and blood samples obtained before and/or after study therapy completion, and/or at the time of disease progression.

A Study of BL-B01D1 Combined With Osimertinib Mesylate Tablets in Patients With Non-small Cell Lung Cancer

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR-sensitive Mutations

The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.

ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

The PFS is defined as the time from the participant's first dose of BL-B01D1 to the first date of either disease progression or death, whichever occurs first.

The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).

The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

Sichuan Baili Pharmaceutical Co., Ltd.

Osimertinib Mesylate Tablets 80 mg, one time a day until disease progression

Osimertinib 80mg oral administration daily until progression or occurring intolerable treatment-related toxic effects or patients withdrawing informed consent(Based on whichever occurs first)

Hao Long, Prof

Ruping Xing

Hao Long, professor

Hao Long, prof

Based on the existing research results, Osimertinibi is effective not only for patients with sensitizing EGFR mutations, but also for other less common EGFR mutations. However, no studies have been done so far regarding the difference in efficacy of various EGFR mutation subtypes. Meanwhile, the presenting studies data of the safety and efficacy of Osimertinib as first-line therapy for NSCLC is very limited. Therefore, this study aims at assessing the safety and efficacy of Osimertinib as First-line therapy for patients with EGFR mutation-positive locally advanced or Metastatic Non-squamous NSCLC as well as the its difference in efficacy of various EGFR mutation subtypes.

Osimertinib as First-line Therapy for Patients With Late-stage Lung Cancer

Osimertinib as First-line Therapy for Patients With EGFR Mutation-positive Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer(NSCLC), a Single-Arm, Open-Lable, Prospective, Multicenter, Phase II Clinical Trial

Patients were images with computed tomography (CT) scan

Sun Yat-sen University

Sun Yat-sen University Cancer Center

JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

JMT101

Osimertinib, 160 mg, Oral administration once daily (one treatment cycle is 4 weeks).

Xiugao Yang

Li Zhang

This study is a phase II, open label, multi-center study to evaluate the efficacy and safety of JMT101 combined with Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer

A Phase II, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Blood samples will be collected at specified timepoints to detect the presence of anti-drug antibodies and neutralizing antibodies against JMT101

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Shanghai JMT-Bio Inc.

APG-1252 will be explored sequentially using a standard 3+3 escalation scheme at the dose escalation phase; Dose of osimertinib will be fixed at 80mg QD based on approved label.

Multiple dose cohorts, 30 minute IV infusion, weekly for 3 weeks of a cycle with 21days.

APG-1252

Osimertinib Mesylate Tablets 40mg/80 mg, one time a day until disease progression

Yifan Zhai, MD

Li Zhang, Professor

LI ZHANG, Professor

Yanqiu Zhao, Professor

Jiuwei Cui, Professor

Ying Cheng, Professor

There are unmet medical needs in patients who resist to EGFR TKIs, especially to osimertinib; APG-1252 shows synergy with osimertinib in both osimertinib treatment naïve and resistant cell lines. This study is to explore the safety and efficacy of the combination of APG-1252 and osimertinib in 3rd generation TKI resistant patients and 3rd generation TKI treatment naïve patients.

This is a multi-center, open-label, Phase 1b study evaluating the adverse events and best dose of the combination of fixed dose AZD9291 with APG-1252 in EGFR-TKI resistant NSCLC patients.

In exploration phase, 3+3 design will be used to determine the MTD/RP2D of the combination of AZD9291 with APG-1252; Dose of AZD9291 will be fixed at 80mg QD, APG-1252 will start with 240mg weekly, then escalate to 320mg weekly and 400mg weekly or decline to 160mg weekly and 80weekly if not tolerate to 240mg weekly dosage.

In expansion phase, IF 1 confirmed PR or CR observed in NSCLC patients who failed 3rd generation EGFR TKI, the exploration of the combination of AZD9291 with APG-1252 in 3rd generation EGFR TKI naïve NSCLC patients will be initiated.

After completing the enrollment of these two cohorts, a new cohort was added: to explore the preliminary efficacy of APG-1252 combined with osimertinib in the treatment of EGFR Exon20 Insertion or other rare mutant NSCLC patients, and enroll 20 subjects.

Patients will be treated in 21-day cycles. APG-1252 administered via intravenous infusion for 30 minutes weekly (,Day 1, 8 15), AZD9291 via oral daily with 80mg.

A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients

A Phase Ib Study of Safety and Efficacy of APG-1252 in Combination With Osimertinib (AZD9291) in EGFR TKI Resistant NSCLC Patients

To determine the maximum tolerated dose (MTD) of APG-1252 in subjects with NSCLC

Recommended Phase 2 dose (RP2D) of APG-1252 in subjects with NSCLC

To assess efficacy in subjects with NSCLC using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Suzhou Yasheng Pharmaceutical Co., Ltd.

Ascentage Pharma Group Inc.

Advanced NSCLC patients who experienced first/second-generation EGFR-TKI failure with T790M mutation negative or who experienced third-generation EGFR-TKI failure and a subsequent platinum-based doublet chemotherapy failure

Cohort 1: NSCLC patients who experienced first/second-generation EGFR-TKI failure with T790M mutation positive; Cohort 2: NSCLC patients who experienced third-generation EGFR-TKI failure

VIC-1911

Osimertinib tablets for oral administration

li zhang, professor

This is a nonrandomized, open phase I dose escalation and extension clinical study designed to evaluate Aurora A inhibitor VIC-1911 tablets in combination with oxitinib in Chinese patients with advanced non-small cell lung cancer The safety, tolerability, pharmacokinetic characteristics and preliminary antitumor efficacy were analyzed.

The entire study included the screening period (28 days prior to initialadministration of the investigational drug) and the treatment period (Cycle) EoT is defined as disease progression or intolerable toxicity or premature withdrawal Out\]) and the safety follow-up period (28 days after EoT). During dose increments and expansions, subjects followed Safety assessment, PK blood collection, imaging examination and efficacy assessment were performed during the visit plan. Observation subject The safety, tolerability, and occurrence of DLT until disease progression, occurrence of intolerable toxicity, Death, withdrawal of informed consent, loss of follow-up or termination of the study by the sponsor shall prevail.

In the dose escalation phase, a total of 2 groups were planned, and 6-12 patients were expected to be enrolled. In the expansion phase, two cohorts are planned, with each cohort expanding to 20-30 patients, and approximately 40-60 patients are expected to be enrolled. A total of 46 to 72 patients were enrolled in this phase I trial

VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer

Phase I Clinical Study of VIC-1911 Combined With Osimertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGRF- Mutation

Safety and tolerability assessed by adverse events(AEs) and serious adverse events (SAEs)

Length of time from the date of first dose of study drug to the first evidence of objective response (CR,PR)

Proportion of subjects with best response of CR, PR or stable disease (SD)

Length of time from the date of first dose of study drug to the first evidence of disease progression or death, whichever is earlier

Length of time from the date of first dose of study drug to date of death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BL-B01D1 Combined With Osimertinib Mesylate Tablets in Patients With Non-small Cell Lung Cancer	NCT05880706	Non-small Cell ...	BL-B01D1 Osimertinib Mes...	18 Years -	Sichuan Baili Pharmaceutical Co., Ltd.
Osimertinib as First-line Therapy for Patients With Late-stage Lung Cancer	NCT03460275	Non-small Cell ...	Osimertinib Mes...	18 Years - 75 Years	Sun Yat-sen University
Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer	NCT05132777	Locally Advance... EGFR Exon20 Ins...	JMT101 Osimertinib Mes...	18 Years -	Shanghai JMT-Bio Inc.
A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients	NCT04001777	EGFR Positive N...	APG-1252 Osimertinib Mes...	18 Years -	Ascentage Pharma Group Inc.
VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer	NCT05489731	Advanced Non-sm...	VIC-1911 Osimertinib Mes...	18 Years - 75 Years	Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd.
A Study of BL-B01D1 Combined With Osimertinib Mesylate Tablets in Patients With Non-small Cell Lung Cancer	NCT05880706	Non-small Cell ...	BL-B01D1 Osimertinib Mes...	18 Years -	Sichuan Baili Pharmaceutical Co., Ltd.

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