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INTEGRIS Health Cancer Institute

Clinical Trials

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ICIO North Study Description July 2024

STUDY NAME

DZ SITE

STUDY Description

ARMS

# PTS

A011801

HER2 + Breast Can be either ER/PR + or -

The COMPASSHER2 Trials (Comprehensive use of Pathologic Response ASSessment to Optimize Therapy In HER2 Postive Breast Cancer): COMPASSHER2 Residual Disease (RD); A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

Must have completed at least 6 cycles of chemotherapy preoperatively or postoperatively

ARM 1- T-DMM1 and placebo x 14 cycles

 

ARM 1 – T-DM1 and tucatinib x 14 cycles

 

 

ALCHEMIST A151216

Non-Squamous Lung

A Screening Trial for AO81105, and E4512 Observational Trial for Genetic Testing in Screening Patients with Stage IB-IIIA Non-Small Cell (Non-Squamous) Lung Cancer that has been or will be removed by Surgery” No neoadjuvant chemo or RT. No locally advanced or met cancer

Pre-Register give 3 blood specimens btw post-surgery to 30 days post registration. Step 1 FFPE Block Collected.

If EGFR confirmed enroll in A081105..

If ALK+ enroll in E4512

   1         

ALCHEMIST A081801

NSCLC

Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST-IO

Must have EGRF, ALK, PD-LI IHC local testing with no identified arrangements. Must have completely resected dz IB (>/= 4cm), II or IIIA NSCLC with negative margins Patients with N2 Disease completely resected are eligible. However, patients with known N2 dz prior to surgery or ineligible.

Initial Therapy:

Arm A: 4 Cycles of Platinum doublet

With Observation afterwards.

Arm B: 4 Cycles of Platinum doublet with 17 cycles of Keytruda

Amr C: 4 Cycles of Platinum doublet + Keytruda with 13 more cycles of Keytruda.
0             

AstraZeneca D4191C00140

Biliary Tract Cancers

A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination with Chemotherapy for the First Line Treatment for Patients with Advanced Biliary Tract Cancers

(TOURMALINE)

Durvalumab 1500 mg plus gemcitabine-based chemotherapy

 

 

EA5182

 

NSCLC

Randomized Phase III Study of Combination AZD9291 (Osimertinib) and Bevacizumab vs. AZD9291 (Osimertinib) Alone as First Line Treatment for Patients with Metastatic EGRR-Mutant Non Small Cell Lung Cancer (NSCLC)

Arm A: Osimertinib 80 mg po daily

Amr B: Osimertinib 80 mg po daily + Bevacizumab 15 mg kg IV every 3 weeks

 

S2302

NSCLC

A Prospective Randomized Study of Ramucirumab + Pemrbolizumab vs. standard of care for participants previously treated with Immnotherapy for Stage IV or recurrent NSCLC

Arm A:   Investigator’s SOC

Arm B:  Ramucirumab + Pembrolizumab

 

NRG-GI008

Study provides Natera Kits free of charge to the patient

 

Stage III

CRC

 

Colon Adjuvant Chemotherapy based on Evaluation of Residucal Disease (Circulate-US) 

Cohort B – ctDNA positive
Stratification – Intended Chemo (5 FU vs. Xeloda)
Randomization

Arm 3 – mFOLFOX 6 or CAPOX for 6 months

A4m 4 – mFOLFIRINOX for 6 months

Cohort A ctDNA-neg
Stratification- Stage IIIA vs IIIB
Intended chemo (5FU vs. Xeloda)
After Randomization:
Arm 1 FOLFOX6 for 3 – 6 months or CAPOX for 3 months.

Arm 2 – Surveillance

 

MorphoSys
MOR208C414

Realmind 

Diffuse Large B Cell Lymphoma

Prospective multicenter observational study of patients with relapsed or refractory diffuse large B-cell lymphoma starting second or third line therapy and not receiving autologous stem cell transplant