Translational research for immune modulating and targeted therapy in advanced or metastatic non-small cell lung cancer, an exploratory NVALT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23268

Enrollment

300

Registered

2017-04-10

Start date

2017-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer Niet-kleincellig longkanker

Interventions

Blood drops and optionally a tumor biopsy

Eligibility

Inclusion criteria

Inclusion criteria: 1. Eligible for immunotherapy or targeted treatment. 2. Written informed consent for registry of patient data and extra blood and tumor biopsy. 3. Age 18 years and older.

Exclusion criteria

Exclusion criteria: 1. Without written informed consent patient will be adopted anonymously in the registry and will not take part of the study. 2. Patients with written informed consent for registry of patient data but no consent for extra blood and tumor biopsy will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
•Relation between adaptive and innate immune status and tumor response rate, PFS and OS. •Relation between gate keeper mutations and complex mutations with tumor response rate, PFS and OS on treatments used by treating physician. •Correlation of the baseline ctDNA level with tumor response rate, PFS and OS •Correlation of the change in ctDNA level after six weeks of treatment to ORR, PFS and OS. •Validated tumor educated platelet algorithm that is associated with increased ORR, PFS and OS. •Validated tumor educated platelet algorithm that is associated with therapy resistance. •Correlation of STM-panel based response assessment with radiological response assessment as performed by CT-thorax. •Correlation of PBMC FACS parameters of lymphoid and myeloid subsets in peripheral blood to tumor response rate, PFS and OS. •Correlation of rare mutation profile, as assessed by NGS on tumor tissue, to tumor response rate, PFS and OS. •Correlation of tumor tissue IHC parameters to tumor response rate, PFS and OS. •Correlation of RNAseq on fresh frozen tumor tissue to tumor response rate, PFS and OS. •Correlation of CT based parameters to tissue parameters and tumor response rate, PFS and OS. •Correlation of differences between CT based (textural) parameters and tissue parameters and tumor response rate.	—

Measure

Time frame

•Relation between adaptive and innate immune status and tumor response rate, PFS and OS. •Relation between gate keeper mutations and complex mutations with tumor response rate, PFS and OS on treatments used by treating physician. •Correlation of the baseline ctDNA level with tumor response rate, PFS and OS •Correlation of the change in ctDNA level after six weeks of treatment to ORR, PFS and OS. •Validated tumor educated platelet algorithm that is associated with increased ORR, PFS and OS. •Validated tumor educated platelet algorithm that is associated with therapy resistance. •Correlation of STM-panel based response assessment with radiological response assessment as performed by CT-thorax. •Correlation of PBMC FACS parameters of lymphoid and myeloid subsets in peripheral blood to tumor response rate, PFS and OS. •Correlation of rare mutation profile, as assessed by NGS on tumor tissue, to tumor response rate, PFS and OS. •Correlation of tumor tissue IHC parameters to tumor response rate, PFS and OS. •Correlation of RNAseq on fresh frozen tumor tissue to tumor response rate, PFS and OS. •Correlation of CT based parameters to tissue parameters and tumor response rate, PFS and OS. •Correlation of differences between CT based (textural) parameters and tissue parameters and tumor response rate.

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Contacts

Public ContactH.J.M. Groen

University Medical Center Groningen (UMCG), Department of Pulmonary Disease, Box 30001

h.j.m.groen@int.umcg.nl+31 (0)50 3616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)