Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing

The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis
compared with standard tissue biopsy analysis for detection of genomic alterations in
patients with advanced lung cancer. Once selected for the study and with full informed
consent, patients will have a blood draw to allow the detection of cancer-related genomic
alterations that are detectable within the blood sample. These results will be compared to
results obtained from genomic profiling via standard tissue biopsy taken as part of routine
care to help determine whether such 'liquid biopsies' can be used to guide treatments in
future patients. The results of the liquid biopsy will not be used to guide treatment
decisions in study participants.

In addition there is data-collection of treatments received for non small cell lung cancer
and the response to these treatments during the first 6 months post tissue and blood
analysis, though no additional visits or procedures are required for the patient beyond the
initial blood draw.

Inclusion Criteria:

- Written, signed and dated informed consent to participate in the study must be given
by the patient in accordance with 21 CFR Part 312, the International Conference on
Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6, and applicable
regulations, before completing any study-related procedures.

- Male and female patients aged 18 years and over diagnosed with stage IIIb/IV
non-squamous NSCLC.

- Arms A and B: Patients intended to initiate first-line treatment according to standard
guidelines. Note, a patient is eligible to receive sterotactic radiosurgery (no
whole-brain radiotherapy). Arm C: Patients who are at a second-line treatment setting
or greater may participate. Note, a patient may be included if they have metastatic
brain lesions. Arms A, B, C: If enrolled in a treatment clinical trial, patients may
also enroll in this study if all eligibility criteria are met.

- Arm A only: Patients intended to initiate first-line treatment according to standard
guidelines who plan to have or have had a recent tumor tissue biopsy taken for
molecular profiling as part of their standard of care.

- Patient must understand and be able, willing and likely to fully comply with all study
procedures and restrictions.

Exclusion Criteria:

- Patients who have received any approved or experimental cancer therapy since their
most recent NSCLC tissue biopsy (Arms A and B)

- Patients who have any other prior metastatic or current second primary cancer (Arms A
and B)

- Patient who has a severe acute or chronic medical or psychiatric condition or
laboratory abnormality that may increase the risk associated with study participation
or may interfere with the interpretation of study results and, in the judgment of the
Investigator, would make the patient inappropriate for entry into this study.