Recruiting PHASE2 Non-small Cell Lung Cancer Stage III

New treatment option for Non-small Cell Lung Cancer Stage III

Official title Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy

ClinicalTrials.gov ID: NCT05398094

What this study is testing

What is Sotorasib?

Sotorasib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer stage iii.

Also referred to as AMG510.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.

Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

1\. Male or female, aged ≤ 80 years old
2\. ECOG performance status of 0-1
3\. Histologically or cytologically confirmed, unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC according to 8th version of the International...
4\. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy.
5\. No prior treatment for unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC.

You likely can't join if

1\. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, ALK translocations or ROS1 mutations
2\. Weight loss \>10% within the previous 3 months
3\. Patients with uncontrolled neuropathy (sensory) grade 2 or greater regardless of cause according to CTCAE v5.0
4\. Major surgery within 28 days of study day 1
5\. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take...
6\. Significant cardiovascular disease, such as New York Heart Association cardiac disease (ClassII or greater), myocardial infarction within 6...

See the full eligibility criteria

Who can join

1\. Male or female, aged ≤ 80 years old
2\. ECOG performance status of 0-1
3\. Histologically or cytologically confirmed, unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic...
4\. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy.
5\. No prior treatment for unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC.
6\. Having a life expectancy ≥ 12 weeks
7\. Patients must be ineligible for concurrent chemo-radiotherapy because of:
Tumor size ≥ 5 cm and lymph node N2 involvement
The target lesion has to be bulky disease and/or more than 35% of the total volume of the two lungs should receive more than 20 Gy (V20) or inadequate pulmonary function
Interstitial Lung diseases
Prior treatment with thoracic radiotherapy for any reason
Or under decision of a tumor committee as inappropriate due to local characteristics to perform treatment upfront
8\. PET-CT at baseline is mandatory to confirm the absence of distant disease and to confirm unresectable disease
9\. PET-CT positive mediastinic adenopathies must be histologically confirmed. Mediastinic involvement could be considered without histological test when no margin can be distinguished in the lymph node mass.
10\. Brain CT or MRI is mandatory
11\. Patients with at least 1 measurable lesion, as defined by RECIST v1.1.
12\. Adequate hematologic and organ function.
13\. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to...
14\. Willingness and ability to comply with scheduled visits and study procedures
15\. For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment).
16\. For female patients of childbearing potential, agreement (by patient and/or partner) to usea highly effective form(s) of contraception that results in a low failure rate (\< 1% per year)when used consistently and...
17\. For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate [\< 1% per year] when...
18\. Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to enrollment.
19\. QTc interval must be ≤ 470 msec in females and ≤ 450 msec in males, based on the average obtained from three ECG.

What rules you out

1\. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, ALK translocations or ROS1 mutations
2\. Weight loss \>10% within the previous 3 months
3\. Patients with uncontrolled neuropathy (sensory) grade 2 or greater regardless of cause according to CTCAE v5.0
4\. Major surgery within 28 days of study day 1
5\. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication
6\. Significant cardiovascular disease, such as New York Heart Association cardiac disease (ClassII or greater), myocardial infarction within 6 months prior to study day 1, unstable arrhythmias or unstable angina
7\. Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval \> 470ms
8\. Severe infections within 4 weeks prior to randomization including, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia
9\. Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization
10\. Patients with any concomitant and uncontrolled medical disorder
11\. Patients with vena cava syndrome
12\. Malignant pleural or pericardial effusion: both will be considered as suggestive of metastaticdisease. Also, are excluded those with negative cytology but being exudates. Patients with non-visible by thoracic X-ray...
13\. Prior treatment with anti-neoplasic drugs
14\. Malignancies other than NSCLC within 3 years prior to enrollment
15\. Women who are pregnant, lactating, or intending to become pregnant during the study.
16\. Positive test for HIV. All patients will be tested for HIV prior to inclusion into the study; patients who test positive for HIV will be excluded from the clinical study.
17\. Patients with active hepatitis B or hepatitis C.
18\. Active tuberculosis.
19\. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug...
20\. Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures.
21\. Known or suspected hypersensitivity to drugs with similar chemical structures to the study drug
22\. Evidence of any other disorder or significant laboratory finding that makes the patient undesirable to participate in the study
23\. Use of strong inducers of CYP3A4 within 14 days of half-lives (whichever is longer) prior to study day 1
24\. Use of proton pump inhibitors within 14 days to study day

The study team makes the final eligibility decision.

Where it's taking place

Alicante, Alicante, Spain
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
Bilbao, Bilbao, Spain
Girona, Girona, Spain
Granada, Granada, Spain
Jaén, Jaén, Spain
A Coruña, La Coruña, Spain
Lugo, Lugo, Spain
Leganés, Madrid, Spain
Madrid, Madrid, Spain
Majadahonda, Madrid, Spain
Palma de Mallorca, Mallorca, Spain
Palma de Mallorca, Palma de Mallorca, Spain
Seville, Sevilla, Spain
Valencia, Valencia, Spain

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Alicante, Alicante, Spain; Badalona, Barcelona, Spain; Barcelona, Barcelona, Spain; Bilbao, Bilbao, Spain; Girona, Girona, Spain; Granada, Granada, Spain and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.