STAR Trials
The US Oncology Research STAR model (Selected Trial for Accelerated Rollout) are a set of studies targeted for rare patient populations. Trials in the STAR program can be made available for consenting patients within a 2-week time frame after a potential research patient has been identified and sponsor has given approval to move forward. Southern Cancer Center is given visibility to the trials included in this rapid activation model.
STAR TRIALS CURRENTLY OPEN
BILIARY CANCER
22033 – STAR: Ph2 TT-00420 Advanced Cholangiocarcinoma
A Phase II, open label, multicenter study to evaluate the efficacy and safety of TT-00420 (tinengotinib) tablet in adult patients with advanced cholangiocarcinoma. (TT420C1206)
22123 – STAR: Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)
Brightline-2: A Phase IIa/IIb, open-label, single-arm, multicenter trial of BI 907828 for treatment of patients with locally advanced/metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumors. (1403-0011)
CARCINOID CANCER
22033 – STAR: Ph2 TT-00420 Advanced Cholangiocarcinoma
A Phase II, open label, multicenter study to evaluate the efficacy and safety of TT-00420 (tinengotinib) tablet in adult patients with advanced cholangiocarcinoma. (TT420C1206)
COLON CANCER
20318 – STAR: Ph3 MRTX849 Cetux KRAS G12C CC
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)
FALLOPIAN TUBE CANCER
21270 – STAR: Ph2 ZN-c3 Tumor DNA Repair CCGA
A Phase 2 open-label, multicenter study to evaluate efficacy and safety of ZN-c3 in subjects with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. (ZN-c3-005| GOG 3066)
LEUKEMIA
18263 – STAR: Zanu in Acala Intolerant B-Cell
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)
LUNG CANCER
20139 – STAR: PH3 EGFRm Stage2/3b NSCLC
A Phase III, randomized, controlled, multicenter, 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)
21318 – STAR: PH1/3 Biomarker Unresectable Stage3 NSCLC
A Phase I-III, multi-center study evaluating the efficacy and safety of multiple therapies in cohorts of patients selected according to biomarker status, with locally advanced, unresectable, Stage II non-small cell lung cancer. (BO42777)
21498 – STAR: Ph1/2 VS-6766 + Soto KRAS G12C NSCLC
A Phase 1/2 study of Avutometinib (VS-6766) in combination with Sotorasib in patients with KRAS G12C mutant non-small cell lung cancer. (NSCLC) (RAMP 203) (VS-6766-203)
22123 – STAR: Ph2/3 BI 907828 MDM2 TP53 WT Select Solids (Brightline-2)
Brightline-2: A Phase IIa/IIb, open-label, single-arm, multicenter trial of BI 907828 for treatment of patients with locally advanced/ metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumors. (1403-0011)
22198 – STAR: Ph3 Furmo v Platinum Chemo in EXON 20 NSCLC EGFR
A global, Phase 3, randomized, multicenter, open-label study to investigate the efficacy and safety of Furmonertinib compared to Platinum-based chemotherapy as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor Exon 20 insertion mutations. (FURMO-004)
20412 – STAR: Ph3 Adj Selp St1B/3 RET+ NSCLC
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)
LYMPHOMA
18263 – STAR: Zanu in Acala Intolerant B-Cell
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)
OVARIAN CANCER
21270 – STAR: Ph2 ZN-c3 Tumor DNA Repair CCGA
A Phase 2 open-label, multicenter study to evaluate efficacy and safety of ZN-c3 in subjects with high-grade serous ovarian, fallopian sube, or primary peritoneal cancer. (ZN-c3-005| GOG 3066)
PANCREATIC CANCER
22123 – STAR: Ph2/3 BI 907828 MDM2 TP53 Select Solids (Brightline-2)
Brightline-2: A Phase IIa/IIb, open-label, single-arm, multicenter trial of BI 907828 for treatment of patients with locally advanced/ metastatic, MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma, pancreatic ductal adenocarcinoma, or other selected solid tumors. (1403-0011)
PERITONEAL CANCER
21270 – STAR: Ph2 ZN-c3 Tumor DNA Repair CCGA
A Phase 2 open-label, multicenter study to evaluate efficacy and safety of ZN-c3 in subjects with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. (ZN-c3-005| GOG 3066).
SOLID TUMORS
22052 – STAR: Ph2 Basket Nab-Siro Solids TSC1 or TSC2 Genes (open at site)
A Phase 2 multicenter, 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)