Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Adenocarcinoma

Lung Diseases

Head and Neck Neoplasms

Neoplasms, Germ Cell and Embryonal

Respiratory Tract Diseases

Thoracic Neoplasms

Respiratory Tract Neoplasms

Carcinoma, Bronchogenic

Neoplasms, Nerve Tissue

Bronchial Diseases

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Amino Acids

Vitamins

Gemcitabine

Paclitaxel

Carboplatin

Pemetrexed

Pembrolizumab

Albumin-Bound Paclitaxel

Cisplatin

Pralsetinib

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Tyrosine

Folinic Acid

Folate

Vitamin B9

Participants randomized to the Experimental Arm will receive Pralsetinib

Participants randomized to the Active Comparator Arm will receive 1 of 6 platinum-based chemotherapy treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating Investigator (based on histology)

Nonsquamous histology

* Carboplatin or cisplatin / pemetrexed (with vitamin supplementation); with optional pemetrexed (with vitamin supplementation) maintenance.
* Pembrolizumab / carboplatin or cisplatin / pemetrexed (with vitamin supplementation); followed by pembrolizumab and optional pemetrexed (with vitamin supplementation) maintenance.

Squamous histology

* Carboplatin or cisplatin / gemcitabine
* Carboplatin with paclitaxel/nab-paclitaxel and pembrolizumab

Nab-Paclitaxel

Clinical Trials

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Defined as the time from randomisation date to the first documented progressive disease (PD), as assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurs first.

Defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as assessed by investigator according to RECIST 1.1.

Defined as the time from randomisation date to death due to any cause.

The intensity of Adverse Events (AEs) will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).

Further characterising safety and tolerability.

Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as assessed by investigator according to RECIST v1.1.

Defined as the proportion of participants who experience a best response of Stable Disease (SD) with a minimum duration of 6 months, a CR, or a PR, as assessed by investigator according to RECIST v1.1.

Defined as the proportion of participants who experience a best response of CR, or PR, or SD, as assessed by investigator according to RECIST v1.1.

Hoffmann-La Roche

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Nutritional and Metabolic Diseases

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Colonic Neoplasms

Endocrine Gland Neoplasms

Protein-Energy Malnutrition

Central Nervous System Neoplasms

Endocrine System Diseases

Carcinoma, Neuroendocrine

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Papillary Thyroid Carcinoma

Thyroid Cancer, Medullary

Neuroendocrine Tumor

Neuroepithelioma

Herbal and Botanical

Cola

Phase 1 - Multiple doses of LOXO-292 (selpercatinib) Phase 2 - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)

LOXO-292

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Nina Karlin

Erminia Massarelli

Lyudmila Bazhenova

Jonathan Goldman

Michael Demeure

Misako Nagasaka

Hyunseok Kang

Minggui Pan

Jennifer Suga

Gerald Falchook

Frederick Wilson

Benjamin Levy

Victor Bernet

Luis Raez

Conor Steuer

Christine Bestvina

Marc Matrana

Ranee Mehra

Lori Wirth

Jacob Sands

Francis Worden

Nehal Lakhani

John Columbus Morris

Saiama Waqar

Fadi Braiteh

Grace Dy

Vamsidhar Velcheti

Alexander Drilon

Jared Weiss

Nathan Pennell

Vineeth Sukrithan

Shivaani Kummar

Devraj Basu

Marcia Brose

Jordan Berlin

Tian Zhang

Vivek Subbiah

Wallace Akerley

Alexander Spira

Mark Burkard

bruce robinson

Benjamin Solomon

Janessa Laskin

Kristoffer Rohrberg

Jacques Medioni

Antoine Italiano

Philippe Cassier

Pascale Tomasini

Diego Tosi

Benjamin Besse

Barbara Deschler-Baier

Jürgen Wolf

Herbert Loong

Talia Golan

Nir Peled

Julia Dudnik

Hovav Nechushtan

Filippo De Braud

Masahiro Morise

Koichi Goto

Jun Sakakibara

Miyako Satouchi

Shinji Takeuchi

Tsutomu Iwasa

Hirotsugu Kenmotsu

YUICHIRO OHE

Makoto Nishio

Tomohiro Sakamoto

Ryo Toyozawa

Kadoaki Ohashi

Haruko Daga

Ji-Youn Han

Yu Jung Kim

Dae Ho Lee

Se Hoon Lee

Byoung Chul Cho

Shao Weng Daniel Tan

Elena Garralda Cabanas

Victor Moreno

Maria Jose de Miguel Luken

Oliver Gautschi

Kuo-Hsuan Hsu

Chih-Hsin Yang

Anna Minchom

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive solid tumors, MTC, and other tumors with RET activation. The trial will be conducted in 2 parts: Phase 1 (dose escalation - completed) and phase 2 (dose expansion). Participants with advanced cancer are eligible if they have progressed on or are intolerant to available standard therapies, or no standard or available curative therapy exists, or in the opinion of the Investigator, they would be unlikely to tolerate or derive significant clinical benefit from appropriate standard of care therapy, or they declined standard therapy. A dose of 160 milligrams (mg) twice a day (BID) has been selected as the recommended phase 2 dose (RP2D). Approximately 875 participants with advanced solid tumors harboring a RET gene alteration in tumor and/or blood will be enrolled to one of seven phase 2 cohorts:

* Cohort 1: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for participants who progressed on or intolerant to first line therapy (open)
* Cohort 2: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer for treatment naïve participants (open)
* Cohort 3: Advanced RET-mutant MTC participants who progressed on or intolerant to first line therapy (closed)
* Cohort 4: Advanced RET-mutant MTC participants who are treatment naïve (closed)
* Cohort 5: Advanced RET-altered solid tumor for participants other than NSCLC or thyroid cancer and RET-mutant MEN2 spectrum tumors (e.g. pheochromocytoma) otherwise ineligible for cohorts 1-4. See details in inclusion/exclusion criteria (open)
* Cohort 6: Participants otherwise eligible for Cohorts 1-5 who discontinued another RET inhibitor due to intolerance may be eligible with prior Sponsor approval (closed)
* Cohort 7: RET fusion positive early-stage non-small cell lung cancer (NSCLC) participants who are candidates for definitive surgery. Participants will receive selpercatinib in a neoadjuvant and adjuvant setting. Participants will be followed for disease recurrence for up to 5 years from the date of surgery (closed)

A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)

Incidence rate and category of dose limiting toxicities (DLTs) during the first 28-day cycle of LOXO-292 (selpercatinib) treatment

As assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO), as appropriate to tumor type, as assessed by independent review committee (IRC)

Phase 1: Number of Participants with a TRAE(s)

Phase 1: Number of Participants with an Abnormal Laboratory or Physical Exam Result(s)

Phase 1: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type

Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator)

Phase 2: Time to Any and Best Response (by IRC and Investigator)

Phase 2: Percentage of Participants with any SAE(s)

Phase 1 and 2: PK: AUC of LOXO-292 (Selpercatinib)

Phase 1 and 2: PK: Cmax of LOXO-292 (Selpercatinib)

Eli Lilly and Company

Loxo Oncology, Inc.

Adenoma

Sarcoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)	NCT04222972	RET-fusion Non ... Lung Neoplasm Carcinoma, Non-... Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra... Carcinoma, Bron... Bronchial Disea... Head and Neck N... Adenocarcinoma Carcinoma Neoplasms by Hi... Neoplasms, Germ... Neoplasms, Nerv...	Pralsetinib Carboplatin Cisplatin Pemetrexed Pembrolizumab Gemcitabine Paclitaxel Nab-Paclitaxel	18 Years -	Hoffmann-La Roche
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)	NCT03157128	Non-Small Cell ... Medullary Thyro... Colon Cancer Any Solid Tumor	LOXO-292	12 Years -	Eli Lilly and Company
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors	NCT03037385	RET-altered Non... Medullary Thyro... RET-altered Pap... RET-altered Col... RET-altered Sol... Lung Neoplasm Carcinoma, Non-... Thyroid Disease... Thyroid Neoplas... Thyroid Cancer,... Carcinoma, Neur... Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra... Carcinoma, Bron... Bronchial Neopl... Endocrine Syste... Endocrine Gland... Head and Neck N... Adenocarcinoma,... Adenocarcinoma Carcinoma Neoplasms, Glan... Neoplasms by Hi... Neuroendocrine ... Neuroectodermal... Neoplasms, Germ... Neoplasms, Nerv... Colonic Neoplas... Colorectal Neop... Intestinal Neop... Gastrointestina... Digestive Syste... Digestive Syste... Gastrointestina... Colonic Disease... Intestinal Dise...	pralsetinib (BL...	18 Years -	Hoffmann-La Roche
Vandetanib in Advanced NSCLC With RET Rearrangement	NCT01823068	Non Small Cell ...	Vandetanib	18 Years -	Samsung Medical Center
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company

Spots Global Cancer Trial Database for ret fusion

Every month we try and update this database with for ret fusion 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 ret fusion

Every month we try and update this database with for ret fusion 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 ret fusion 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.