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

Bladder

20172 STAR
A Phase 2 study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer (SGN22E-002)

  • TX Line(s) – 1st Line Locally Advanced/Metastatic

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

14059 STAR
Phase I/II trial of Ibrutinib plus Trastuzumab in HER2-amplified Metastatic Breast Cancer

  • TX Line(s) – 2nd line/Metastatic
  • Biomarker – Her2 amplified

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

Esophageal Cancer/GEJ/Gastric

20409 STAR
A Phase 2, Multi-Center, Open-Label Study of Cinrebafusp Alfa (PRS-343) in Combination with Ramucirumab and Paclitaxel in Patients with HER2-Positive Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination with Tucatinib in Patients with HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma(PRS-343-PCS_09_20)

  • TX Line(s) – 1st or 2nd line
  • Biomarker – HER2+

20171 STAR
A Phase 3, Multicenter, Double-Blind, Randomized Phase III Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination with Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)CIBI308A301.

  • TX Line(s) – 1st Line Locally Advanced/Metastatic

Head and Neck

21459 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

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)

  • TX Line(s) – 2nd or 3rd line
  • Biomarker – KRAS G12C

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).

20249 STAR
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (61186372NSC3001)

  • TX Line(s) – 2nd line or Metastatic
  • Biomarker – EGFR Exon 20ins activating mutation

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)

  • 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

20177 STAR
M16-191: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Navitoclax in Combination with Ruxolitinib versus Ruxolitinib in Subjects with Myelofibrosis

  • TX Line(s) – 1st or 2nd line

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