Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

AROS-1 : A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

12+Age Over 12

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAcute Lymphoblastic Lymphoma,Adrenocortical carcinoma,Anus,Astrocytoma,Basal cell carcinoma,B-Cell Non Hodgkin Lymphoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cancer of Unknown Primary,Central Nervous System,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Diffuse Large Cell Lymphoma,Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Follicular Lymphoma,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastrointestinal stromal tumors (GISTs),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Glioblastoma (GBM) ,Glioma,Head and neck,Hodgkin's Disease (Hodgkin's Lymphoma),Kidney,Langerhans Cell Histiocytosis,Leiomyosarcoma,Liposarcoma,Liver,Lung,Lymphoma,Mantle Cell Lymphoma,Medullablastoma,Melanoma (Ocular),Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Paroxysmal Nocturnal Hemoglobinuria (PNH),Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Skin Lymphoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Squamous cell carcinoma ,Stomach,Synovial Sarcoma,T-Cell Lymphoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva,Wilm's tumour

Trial Overview Read MoreRead more

This phase I/II study is seeking to determine the best dose level, safety and effectiveness of a new cancer drug (NVL-250) in people with locally advanced solid cancers.
 

This trial is treating patients with ROS1-positive non-small cell lung cancer and other advanced ROS1-positive solid cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You are currently receiving treatment for your cancer.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)

Commercial Sponsor

Nuvalent Inc.

Summary

This study has two parts. Phase 1 will determine the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of NVL-520 in people with advanced ROS1-positive solid cancers. In this phase, NVL-520 will be given orally, daily. Phase 2 will determine the objective response rate (ORR) and effectiveness of NVL-520 in people with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid cancers. Phase 2 will have 5 cohorts. Cohort 2a will recruit people with ROS1-positive NSCLC who are naive to Tyrosine Kinase Inhibitor (TKI) therapy. Cohort 2b will recruit people with ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior platinum-based chemotherapy with or without immunotherapy. Cohort 2c will recruit people with ROS1-positive NSCLC who have been treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy. Cohort 2d will recruit people with ROS1-positive NSCLC who have been treated with ≥2 prior ROS1 TKIs and up to 1 prior platinum-based chemotherapy with or without immunotherapy. Cohort 2e will recruit people with ROS-1 positive solid cancers who have progressed on any prior therapy.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Rachel McMenamin
PCCTU.MoncB@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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