ASPiRATION - An observational cohort study assessing the clinical impact of comprehensive genomic profiling in people with newly diagnosed metastatic lung cancer.

Not Applicable

Active, not recruiting

• Conditions: Metastatic lung cancer; Metastatic non-squamous non-small cell lung cancer (mNSCLC); Cancer - Lung - Non small cell

• Registration Number: ACTRN12621000221853
• Lead Sponsor: Australian Genomic Cancer Medicine Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-03
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Male or female patients, aged 18 years and older, with newly diagnosed pathologically confirmed metastatic non-squamous non-small cell lung cancer (mNSCLC);
a. Exception: patients with a typical pattern of disease recurrence within 12 months following primary resection may not require a confirmatory repeat biopsy, unless the diagnosis is unclear, such as an isolated pulmonary nodule, in which case repeat biopsy should be considered per standard practice;
b. For mixed or other histologies the following is permitted:
- Mixed adenosquamous where adenocarcinoma is dominant
- Carcinoma not otherwise specified (NOS) favouring adenocarcinoma
- Sarcomatoid carcinoma
2. ECOG performance status 0 or 1.
3. Sufficient tissue for molecular screening.
4. Willing and able to comply with study requirements. It is the intention to screen patients who are in principle willing to consider participation in a MoST substudy if they are found to have an appropriate tumour biomarker and are still eligible for enrolment at the time of the treatment phase;
5. Current enrolment or participation in another clinical study with an unregistered investigational product during the last 12 months, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study, must first be discussed the Study Team before study enrolment.
6. Signed, written informed consent to participate in molecular profiling and linkage to Medicare data.
7. Have not had any previous treatment for metastatic non-squamous NSCLC;
a. For patients with symptomatic or bulky disease, where it would be detrimental to delay treatment, systemic therapy may be commenced at the investigator’s discretion whilst awaiting CGP results;
b. Patients who have had prior treatment with curable intent are eligible.
8. Life expectancy of at least 12 weeks.

Exclusion Criteria

1. Ineligible histology:
- Mixed small cell lung cancer
- Large cell neuroendocrine carcinoma
2. Comorbidities or conditions (e.g. psychiatric) which may contraindicate participation and/or ability to receive any systemic therapy(s);
3. Comorbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
4. History of another primary malignancy except for:
a. Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence
b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
c. Adequately treated carcinoma in situ without evidence of disease

Study & Design

• Study Type: Observational
• Study Design: Not specified