Anal
20189 STAR
A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2) (INCMGA 0012-303)
- TX Line(s) – 1st line – prior neoadjuvant or adjuvant therapy is permitted if completed > 6 months prior
Breast
21448 STAR
Open-Label Study of Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients with Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting (G1T28-213)
- TX Line(s) – 2nd line or More
- Biomarker – ER-negative, PR-negative, and HER2-negative
Colon
19151 STAR
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) For all solid tumor designations with a G12C mutation.
- TX Line(s) – 2nd line/Metastatic – Cohorts A and B, patients must have previous treatment with at least a platinum & checkpoint inhibitor therapy.
- Biomarker – Genomic testing for KRAS if not previously performed, KRAS G12C
20318 STAR
A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy (849-010)
- TX Line(s) – 2nd line
- Biomarker – KRAS G12C mutation
Head and Neck
21459 STAR
Ph1 FIH CUE101 Mono/Combo w/Pembro HNSCC (available to non Phase 1 sites)
- TX Line(s) – Recurrent/Mets
- Biomarker – HPV16 positive and express p16INK4A
19171 STAR
A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelets Counts <50,000/µL) (PAC203)
- TX Line(s) – 1st or 2nd line
- Biomarker – DIPSS Intermediate-1, Intermediate 2, or High risk Prior ruxolitinib treatment with failure to benefit or intolerance
Leukemia/Lymphoma
18263 STAR
A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients with Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment with Ibrutinib and/or Acalabrutinib (BGB-3111-215)
- TX Line(s) – Minimum of 1 prior line of standard chemotherapy
20282 STAR
An open label, multi-center Phase IIIb study of asciminib (ABL001) monotherapy in previously treated patients with chronic myeloid leukemia in chronic phase (CML-CP) with and without T315I mutation (AIM4CML)(CABL001AUS04)
- TX Line(s) – 2nd line
- Biomarker – NGS, T315I
11282 STAR
A Phase 2 Open-Label Study of Brentuximab Vedotin in Front-Line Therapy of Hodgkin Lymphoma (HL) in Adults age 60 and Above
- TX Line(s) – 1st line
Lung
21239 STAR
A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure (61186372NSC3002)
- TX Line(s) – Locally advanced or metastatic 2nd or 3rd line with most recent treatment being Osimertinib
- Biomarker – EGFR Exon 19del or Exon 21 L858R mutation
19151 STAR
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001). All Sites can participate in the Ph1b & Ph2
- TX Line(s) – Treatment Naïve, 2nd line
- Biomarker – KRAS G12C, KRAS G12C and STK11
21498 STAR
Ph1/2 VS-6766 + Soto KRAS G12C NSCLC-A Phase 1/2 Study of VS-6766 in Combination with Sotorasib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP 203) (VS-6766-203) **2 slots re-opened for the dose level VS-6766 4.0 mg VIW + sotorasib 960 mg QD**
- TX Line(s) – 2nd or 3rd line
- Biomarker – KRAS G12C
21318 STAR
Phase I-III Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Biomarker-selected Patients with Locally Advanced Stage III Non-Small Cell Lung Cancer
- TX Line(s) – Prior receipt of at least two prior cycles of platinum-based chemot given with radiotherapy (cCRT); or at least two prior cycles of platinum-based chemotherapy given prior to radiotherapy (sCRT)
- Biomarker – ALK, ROS-1, RET
20139 STAR
A Phase III, Randomised, Controlled, Multi-centre, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination with Chemotherapy versus Standard of Care Chemotherapy Alone for the Treatment of Patients with Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA) (D516AC00001)
- TX Line(s) – Neoadjuvant
- Biomarker – Mutation in EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).
20270 STAR Ph2 MRTX849 Pembro NSCLC KRAS
A Phase 2 Trial of MRTX849 in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation (849-007)
- TX Line(s) – Advanced unresectable or Metastatic
- Biomarker – KRAS G12C
20331 STAR
A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and in Combination with Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) Non-Small Cell Lung Cancer (NSCLC)(VS-6766-202). Part B Status: Not Moving Forward – Part A Status: Reopen for Enrollment.
- TX Line(s) – Metastatic
- Biomarker – In Part A of the study, subjects must have either a KRAS-G12V mutation or ANY other KRAS mutation (KRAS-other, including KRAS-G12C & G12D).
21219 STAR
RMC-4630-03: A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects with KRAS G12C Mutation After Failure of Prior Standard Therapies
- TX Line(s) – locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery)
- Biomarker – KRASG12C
20412 STAR
A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC (LIBRETTO-432) (J2G-MC-JZJX)
- TX Line(s) – Adjuvant
- Biomarker – Central labs for RET testing
Myelofibrosis
20346 STAR
A PHASE 2, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF SINGLE AGENT SELINEXOR VERSUS TREATMENT OF PHYSICIANíS CHOICE IN PATIENTS WITH PREVIOUSLY TREATED MYELOFIBROSIS (XPORT-MF-035)
- TX Line(s) – 2nd line
- Biomarker – MPN Mutation Panel
Ovarian
20298 STAR
A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Alone and In Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)(VS-6766-201 | GOG 3052)
- TX Line(s) – 2nd line metastatic
- Biomarker – Known KRAS mutation Status
Prostate
20138 STAR
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer(mHSPC)Characterised by PTEN deficiency (CAPItello-281) D361BC00001
- TX Line(s) – 1st line Metastatic
- Biomarker – PTEN mutation
20248 STAR
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)(67652000PCR3002)
- TX Line(s) – 2nd line metastatic
- Biomarker – one of the following: BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, PALB2, RAD51B, RAD54L
Solid Tumors
19151 STAR
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001)
- TX Line(s) – Other solid tumors see Amend 9 flyer
- Biomarker – KRAS G12C- other mutations when no other treatment options- Phas2 portion
21270 STAR
A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN‑c3 in Subjects with Malignant Tumors Harboring DNA Repair and Cell Cycle Gene Alterations (ZN-c3-005| GOG 3066)
- TX Line(s) – prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or no standard therapy exists for their tumor type/stage. Prior treatment with immune checkpoint inhibitors is allowed.
- Biomarker – MRE11, RAD50, or NBN or CCNE1 amplifications
20245 STAR
CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors (ELVCAP-001-01)
- TX Line(s) – 2nd line
- Biomarker – NRG1 gene fusion
22052 STAR
Ph2 open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes (TSC-007)
- TX Line(s) – Received all SOC therapies appropriate for their tumor type OR investigator determines no clinical benefit from SOC and no satisfactory alternative treatments
- Biomarker – TSCI1 or TSC2 genes alterations