Carcinex Inc

Our mission is to build a new oncology ecosystem with our solid tumor cancer drug called Carboxamil. Carboxamil (Cromolyn sodium) is an FDA approved drug that we have repurposed for all solid tumor cancers. Carboxamil will transform the lives of those affected by late- stage cancer where there is no effective treatment. 

Expanded access, also referred to as compassionate use, is one potential pathway for people with life-threatening diseases to gain early access to an investigational medicine outside of a clinical trial when no satisfactory alternative treatment is available. Carcinex is offering expanded access/ compassionate use in local advanced stage 3 lung cancer. In alignment with FDA regulation Carcinex considers the following criteria to determine if Carboxamil for local advanced stage 3 lung cancers can be made available.

Inclusion Criteria 

Patients with local advanced stage 3 lung cancer will be eligible for the study only if they meet the following criteria:

· Provide written informed consent prior to screening. 

· Male or female patients, age ≥ 18 years 

· Histological- or cytological-confirmed diagnosis of Lung cancer

· Previous tumor scan location in lung

Exclusion Criteria

· Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5 half-lives of study agent, whichever is longer. 

· Patients with known pericardial effusion 

· Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator) 

· Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. 

· Patients with any other medical condition that in the opinion of the Investigator would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study.

· Known allergy or history of serious adverse event with Cromolyn Sodium

It’s important to remember that investigational medicines have not yet received regulatory approval; therefore, their potential risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking expanded access to an investigational medicine. We encourage individuals to speak directly with their treating physician regarding current or future options, clinical trials, and expanded access programs.