Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

CLN-081 BID in single patient dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations that either have received or never received prior EGFR TKIs.

CLN-081 BID in Rolling Six dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations.

CLN-081 BID in expansion cohorts that may be opened at doses that meet pre-specified efficacy and safety criteria.

Single-dose CLN-081 150 mg with and without high fat food intake.

CLN-081 BID in NSCLC patients with EGFR exon 20 insertion mutations that have received prior systemic therapy for locally advanced or metastatic disease.

CLN-081 BID to patients with EGFR exon 20 insertion mutant NSCLC after prior therapy with an agent approved for the treatment of ex20ins mutant NSCLC.

CLN-081

Shengting Li, MD, PhD

Jackie Bronicki

Elizabeth Brown

Veena Charu

Valeria Estala

Danny Nguyen, MD

Juan Miranda

Danny Nguyen

Jesse Ruiz

Jeffrey Kettler

Mark Socinski, MD

Olivia Deloney

Zosia Piotrowska, MD

Dhaman Bansal

Gregory Kalemkerian

Michelle Mackenzie

Sarada Gurubhagavatula

Tomislav Vucetic

Vamsidhar Velcheti, MD

Moury Minhaz

Catherine Shu, MD

Khadeja Moses

Helena Yu, MD

Amanda Rich

Nashat Y Gabrail, MD

Lynn Freitas

Rachel E Sanborn, MD

Rachel Sanborn

Keagan Buttigieg

Timothy Burns, MD, PhD

Jessica Shealor

John Wrangle, MD

Karina Castillo Grady

Alex Spira, MD, PhD

Mike Law

Victor Ho-Fun Lee, MBBS

Francesca Zepponi

Lorenzo Antonuzzo, MD, PhD

Michela Burattini

Rossana Berardi, MD

Martina Magnani

Angelo Delmonte, MD

Daniela Brambilla

Antonio Passaro, MD, PhD

Elisa Pettorelli

Michela Maur, MD

Alessandra Carbone

Diego Cortinovis, MD

Michela Spreadfico

Chiara Bennati, MD

Yuka Sakamoto

Shigeki Umemura, MD, PhD

Yoshihiro Kusama

Hiroshi Tanaka, MD, PhD

Ai Kitamoto

Haurko Daga

Tatsuya Takeuchi

Nishino Kazumi, MD, PhD

Tomomi Endo

Haruyasu Murakami, MD, PhD

Hiroko Kawaguchi

Yuichiro Ohe, MD, PhD

Yurina Nishizawa

Satoru Kitazono, MD, PhD

KyoungSuk Kwon

Ji-Youn Han, MD, PhD

YeonSeon Jeon

Se Hyun Kim, MD

SoHee Choi

Hee Kyung Ahn, MD

Jin MinHee

Jun Hyeok Lim, MD

Jungkyo Kim

Se-Hoon Lee, MD, PhD

Gyeong Min

Sang-we Kim

Ye Song Kim

Sung-Yong Lee

Ji Eun Seo

Hyun Woo Lee

EunYeong Lee

Byoung Yong Shim

Marianne Mahn

Gerrina Ruiter

Kristen Wilkens-Bak

Egbert Smit, MD, PhD

Sheryl St Chong

Ross Soo, MBBS

Vivian Oo Shiyun Fequira

Daniel Shao Weng Tan, MBBS, PhD

Graciela Vanesa Alvarez

Maria Rosario Garcia Campelo, MD

Anna Clua

Laura Mezquita Perez, MD, PhD

Jose Garcia Ruiz

Julia Giner Joaquin, MD

Ana Matres Rojo

Enriqueta Felip Font, MD, PhD

Antonio Davila

Ernesto Samuel Nadal Alforia, MD, PhD

Monica Alemany

Tatiana Hernandez, MD

Elia Garcia Ojeda

Delvys Rodriguez Abreu, MD, PhD

Cristina Rodriguez Villar

Antonio Calles Blanco, MD

Carmen Garcia Delgado

Mariano Provencio Pulla, MD, PhD

Uxue Nunez

Valentina Boni, MD

Alicia Medina Ramos

Manual Cobo Dols, MD, PhD

Sara Diaz

Eduardo Castanon Alvarez, MD

Carmina Rodrigo

Oscar Juan Vidal, MD, PhD

Chien-Ting Hung

Yu-Ching Lin, MD, PhD

Lung-Ying Huang

Gee-Chen Chang, MD, PhD

Wen-Ling Chen

Tsung-Ying Yang, MD, PhD

Jin-Rong Chen

James Chin-Hsin Yang, MD

Chen-chuan Chu

Chao-Hua Chiu, MD

CLN-081-001 is a Phase 1/2, open label, multi-center study of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring EGFR (epidermal growth factor receptor) exon 20 insertion mutations, to characterize the safety, determine the recommended Phase 2 dose (RP2D), and evaluate efficacy.

This is a Phase 1/2, open-label, multicenter, first-in-human trial to evaluate the safety and tolerability, PK, PD, and efficacy of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

This trial is divided into multiple parts: Phase 1 Dose Escalation, Phase 2a Dose Expansion, Module A, Module B, and Module C.

The objectives of the dose escalation and dose expansion parts are to determine the safety, tolerability, recommended Phase 2 dose (RP2D), and preliminary anti-tumor activity of orally administered CLN-081 monotherapy.

The objective of Module A is to preliminarily assess the effect of food on the PK profile of CLN-081.

The objective of Module B is to further characterize the safety and efficacy of CLN-081 monotherapy in patients with EGFR exon 20 insertion mutation NSCLC who have received prior systemic anti-cancer treatment for locally advanced or metastatic disease.

The objective of Module C is to explore the safety, tolerability, and efficacy of CLN-081 monotherapy in patients with EGFR exon 20 insertion mutation NSCLC who have received prior treatment with an agent approved for EGFR exon 20 insertion mutant NSCLC

CLN-081 will be dosed twice daily (BID).

A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

Cullinan Therapeutics Inc.

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Pemetrexed

Cisplatin

Mitogens

Part A: Safety Lead-In Approximately 6-12 patients will receive zipalertinib administered at an initial dose of zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or cisplatin on a 21-day cycle. Patients may continue to receive study treatment until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first.

Enrollment into the Phase 3 portion of the study will begin following completion of Part A.

Approximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day cycle.

Carboplatin or cisplatin will be administered for 4 cycles. Patients may continue to receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until documentation of PD or until other withdrawal criteria are met, whichever comes first.

TAS6417

Taiho Oncology, INC

Ramalingam Ratnasabapathy

Nashat Gabrail

Yutaka Fujiwara

Hisashi Tanaka

Masafumi Yamaguchi

Katsuhiko Naoki

Satoshi Ikeda

Yoshihiko Sakata

Shunichi Sugawara

Kadoaki Ohashi

Takayasu Kurata

Akihiro Tamiya

Ryo Ariyasu

Haruko Daga

Takako Inoue

Sayed Hashemi

Santiago Viteri Ramírez

Florencia Garcia Casabal

Ana Laura Ortega-Granados

Francisco Javier de Castro Carpeno

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.

This study will evaluate the efficacy and safety of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin) in patients with previously untreated, locally advanced or metastatic nonsquamous NSCLC harboring EGFR ex20ins mutations.

The study will be conducted in two parts:

* Part A: Safety lead-in to determine the recommended dose of zipalertinib in combination with standard chemotherapy pemetrexed and a platinum agent (either carboplatin or cisplatin) to be studied in Part B of the study.
* Part B: Randomized, controlled, open-label, multinational Phase 3 study to assess the efficacy and safety of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin) compared to standard chemotherapy alone. Patients randomized to the chemotherapy-only treatment arm in Part B may receive treatment with zipalertinib as monotherapy after BICR-assessed progressive disease (PD) is documented (optional "crossover arm").

An independent data monitoring committee (IDMC) will be established to monitor interim safety Data.

A treatment cycle is defined as 21 days for both parts of the study.

Part A: Safety Lead-In The primary objective of Part A is to determine the recommended dose of zipalertinib administered in combination with pemetrexed and a platinum agent (either carboplatin or cisplatin) to be studied in the Phase 3 portion of this study.

Approximately 6-12 patients will receive zipalertinib administered at an initial dose of zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or cisplatin on a 21-day cycle. Patients may continue to receive study treatment until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first. Patients will be enrolled using a rolling-6 design,35 and the determination of the dose of zipalertinib to be used in Part B of the study will be informed by the incidence of dose-limiting toxicities (DLTs) observed during Cycle 1.

Part B: Phase 3 Enrollment into the Phase 3 portion of the study will begin following completion of Part A.

Approximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day cycle.

Carboplatin or cisplatin will be administered for 4 cycles. Patients may continue to receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until documentation of PD or until other withdrawal criteria are met, whichever comes first.

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

Randomized, Controlled, Open-label, Phase 3, Global Multi - Center Trial to Assess the Efficacy and Safety of Zipalertinib Plus Chemotherapy Versus Chemotherapy Alone, in Patients With Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. This scale is numbered from 0 to 100. The higher the score the better the outcome

The EORTC QLQ-C30 is a "core questionnaire" which incorporates a range of physical, emotional and social health developed to assess the quality of life of cancer patients. This scale is numbered from 30 to 130. The higher the score equates to better functioning.

The NSCLC- SAQ was developed to incorporate the patient's perspective into evaluation of clinical benefit in advanced non-small cell lung cancer trials.. Qualitative evidence supports 7 items covering 5 symptom concepts with the total score measuring overall severity of the following NSCLC symptoms: cough, pain, dyspnea, fatigue, and appetite. Lower scores indicate lower symptom severity.

Taiho Oncology, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer	NCT04036682	Non Small Cell ... EGFR Exon 20 Mu...	CLN-081	18 Years -	Cullinan Therapeutics Inc.
REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)	NCT05973773	Advanced or Met...	TAS6417	18 Years -	Taiho Oncology, Inc.
REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)	NCT05973773	Advanced or Met...	TAS6417	18 Years -	Taiho Oncology, Inc.

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Spots Global Cancer Trial Database for tas6417

Every month we try and update this database with for tas6417 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 tas6417 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.