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Non-squamous, Non-Small Cell Lung CancerUpSwinGNCT04179890

The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib

An observational study of Non-squamous, Non-Small Cell Lung Cancer, run by Boehringer Ingelheim at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced NSCLC harbouring EGFR mutations and treated with an EGFR-TKI Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-squamous, Non-Small Cell Lung Cancer
What is being tested?
Afatinib (Gi(l)otrif®), Erlotinib (Tarceva®) and Gefitinib (IRESSA®)
Type of treatment
Pill or oral medicine
How many people
462 participants
Where
1 siteUnited Kingdom
Study dates
17 Dec 2019to 22 Jul 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naïve advanced EGFR mutated non-small cell lung cancer (NSCLC),

Who may be able to join

  • Adult patients
  • Diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naive advanced EGFR mutated non-small cell lung cancer (NSCLC),
  • treated for Epidermal Growth Factor Receptor (EGFR) mutated NSCLC within regular clinical practice.
  • Informed and privacy consent signature must be obtained depending on local regulations.
  • More specific inclusion criteria for each cohort are the following:
  • Uncommon mutation cohort:
Show all 12Show fewer
  • Patients harbouring uncommon or compound EGFR mutations
  • Patients who started with either afatinib (Gi(l)otrif®), gefitinib (Iressa®), erlotinib (Tarceva®), or osimertinib (Tagrisso®) in the first- or second-line setting within regular clinical practice
  • Patients must have started EGFR-TKI treatment at least 12 months prior to data entry.
  • Sequencing cohort:
  • 5. Patients with common EGFR mutations (Del19, L858R) 6. Patients were treated with afatinib (Gi(l)otrif®) in the first-line setting and for acquired T790M mutation with osimertinib in the second line; 7. Patients must have started osimertinib treatment at least 10 months prior to data entry.
  • Patients treated with osimertinib within an early access program/ compassionate use program (EAP/CUP) are allowed

Who cannot join

  • Patients treated for EGFR mutated NSCLC within a clinical trial or participated in GioTag study.
  • Patients with active brain metastases at start of EGFR-TKI therapy (independent of treatment line)
  • For uncommon mutation cohort: Patients treated with osimertinib with no further uncommon mutation than acquired T790M Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Royal Marsden Hospital

    London, SW3 6JJ

Other trials in United Kingdom

About this study

Official title: UpSwinG: Real World Study on TKI Activity in Uncommon Mutations and Sequencing Giotrif®

Non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced NSCLC harbouring EGFR mutations and treated with an EGFR-TKI

Being tested
Afatinib (Gi(l)otrif®), Erlotinib (Tarceva®), Gefitinib (IRESSA®), Osimertinib (Tagrisso®)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Afatinib (Gi(l)otrif®)Drug

    Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.

  • Erlotinib (Tarceva®)Drug

    Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.

  • Gefitinib (IRESSA®)Drug

    Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.

  • Osimertinib (Tagrisso®)Drug

    Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.

  • Afatinib (Gi(l)otrif®)Drug

    As first line therapy.

  • Osimertinib (Tagrisso®)Drug

    In the case the T790M resistance mutation was developed (second line therapy).

Study groups in NCT04179890
Study groupRoleWhat they receive
Uncommon EGFR mutation cohortThis arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy: * Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®). * Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®). * Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®). * Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib). In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
Receives: Drug: Afatinib (Gi(l)otrif®); Drug: Erlotinib (Tarceva®); Drug: Gefitinib (IRESSA®); Drug: Osimertinib (Tagrisso®)
Sequencing cohortThis arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence: - Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
Receives: Drug: Afatinib (Gi(l)otrif®); Drug: Osimertinib (Tagrisso®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)

    Uncommon Mutation Cohort: Time on treatment with EGFR-TKI assessed as the time from start of EGFR-TKI treatment until the end of treatment or death by any cause is reported.

    Common mutation cohort: Time on treatment with EGFR-TKI assessed as the time from start of afatinib (Gi(l)otrif®) as first-line treatment until the end of the second line treatment (the last dose of osimertinib) or death date by any cause.

    Time on treatment was analysed using Kaplan-Meier method, and the median was tabulated along with two-sided 95% confidence interval using the Greenwood's variance estimate.

    Measured: Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.

Secondary outcomes (15)
  1. Uncommon Epidermal Growth Factor Receptor (EGFR) Mutation Cohort: Overall Response Rate to Index Line Treatment

    Overall response rate (ORR) using RECIST criteria as assessed by investigator. ORR to index line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) treatment is reported (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)).

    (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR).

    Measured: Up to 13 years.

  2. Sequencing Cohort: Overall Response Rate to First Line Afatinib

    Overall response rate (ORR) using RECIST criteria as assessed by investigator. Overall response rate to first line afatinib treatment for the Common Epidermal Growth Factor Receptor (EGFR) mutation cohort is reported. (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)).

    (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR).

    Measured: Up to 6 years.

  3. Sequencing Cohort: Overall Response Rate to Second-line Treatment Osimertinib

    Overall response rate (ORR) using RECIST criteria as assessed by investigator. Overall response rate to second-line treatment (Osimertinib) is reported. (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)).

    (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR).

    Measured: Up to 6 years.

  4. Overall Survival

    Uncommon Mutation Cohort: Overall survival since index line treatment start of Tyrosine Kinase Inhibitor (TKI) medication administered per generation until death date by any cause or the end of index line is reported. Sequencing cohort: Overall survival for since first-line afatinib treatment start until death date by any cause or the end of index line. Kaplan-Meier estimates of quartiles of time to death were computed (with their 95% Confidence Intervals, using Greenwood's variance estimate.

    Measured: Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.

  5. Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start

    Number of participants for each type of biological samples used for mutation detection at first line treatment start is reported.

    The reported types of biological samples are:

    • Tissue, histological sample (solid biopsy);
    • Cytological sample;
    • Blood (liquid biopsy);
    • Other and
    • Unknown.

    Measured: At first-line treatment start (i.e. between 2007 and 2019 for the Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 2018 for Sequencing Cohort).

  6. Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start

    Number of participants for each type of methodologies used for mutational testing is reported.

    The reported types of methodology are:

    • Amplification Refractory Mutation System (ARMS);
    • Polymerase Chain reactions (PCR)-based techniques;
    • Sequencing;
    • Next-Generation Sequencing (NGS);
    • Other;
    • Unknown.

    Measured: At first-line treatment start (i.e. between 2007 and 2019 for the Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 2018 for the Sequencing Cohort).

  7. Uncommon Mutation Cohort: Time on Treatment Until Failure of Second-line (TTF2)

    Time on treatment until failure of second-line (TTF2), defined as time elapsed from start of first-line treatment (regardless the type of treatment) to stop of second-line (regardless of the type of treatment) or death by any cause is reported. Kaplan-Meier estimates of quartiles of time to second-line treatment failure were computed (with their 95% Confidence Intervals, using Greenwood's variance estimate).

    Measured: From start of first-line treatment to stop of second-line or death by any cause, up to 13 years.

  8. Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start

    Number of participants for each type of biological samples used for mutation detection at second line treatment start is reported.

    The reported types of biological samples are:

    • Tissue, Histological sample (solid biopsy);
    • Cytological sample;
    • Blood (liquid biopsy);
    • Not applicable-Clinical evaluation;
    • Other;
    • Unknown. Not applicable - Clinical evaluation: The uncommon Epidermal Growth Factor Receptor (EGFR) mutational status had become available after Progression on conventional second-line therapy. Erlotinib was given as state of the art second-line therapy in 2014, and an EGFR mutation was clinically suspected due to the Long-Lasting response. However, due to the unavailability of tumor tissue, this could be proven only after liquid biopsy had subsequently become available at the center in 2016.

    For the Sequencing cohort second-line treatment start is initiated by the beginning of the therapy with Osimertinib.

    Measured: At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for "Uncommon EGFR mutation cohort" and between 2014 and 23-Oct-2020 for the "Sequencing Cohort

  9. Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation

    Number of participants for each type of biological samples used for mutation detection at second line treatment stop/end of observation is reported.

    The reported categories of biological samples are:

    • Tissue, Histological sample (solid biopsy);
    • Cytological sample;
    • Blood (liquid biopsy);
    • Other.

    Measured: At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).

  10. Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start

    Number of participants for each type of biological samples used for mutation detection at index therapy start (index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line)) is reported.

    The reported categories of biological samples are:

    • Tissue, Histological sample (solid biopsy);
    • Cytological sample;
    • Blood (liquid biopsy);
    • Other and
    • Unknown.

    Measured: Up to 13 years.

  11. Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start

    Number of participants for each type of methodology used for mutational testing at second-line treatment start is reported.

    The reported types of methodologies are:

    • Amplification Refractory Mutation System (ARMS);
    • Polymerase Chain Reaction (PCR)-based techniques;
    • Sequencing;
    • Next-Generation Sequencing (NGS);
    • Other;
    • Unknown/Not applicable- Clinical evaluation.

    Measured: At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).

  12. Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation

    Number of participants for each type of methodology used for mutational testing is reported.

    The reported types of methodologies are:

    • Polymerase Chain Reaction (PCR)-based techniques;
    • Next-Generation Sequencing (NGS);
    • Unknown.

    Measured: At second-line treatment stop/end of observation (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).

  13. Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start

    Number of participants for each type of methodology used for mutation detection at index therapy start is reported. Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line).

    The reported categories of methodology are:

    • Amplification Refractory Mutation System (ARMS),
    • Polymerase chain reaction based techniques (PCR-based techniques),
    • Sequencing,
    • Next-Generation Sequencing (NGS),
    • Unknown.

    Measured: Up to 13 years.

  14. Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line

    Number of participants for each type of methodology used for mutation detection at start of first-line chemotherapy before index line is reported.

    The reported types of methodologies are:

    • PCR-based techniques;
    • Sequencing;
    • Next-Generation Sequencing (NGS);
    • Unknown.

    Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line).

    Measured: At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).

  15. Uncommon Mutation Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line

    Number of participants for each type of biological samples used for mutation detection at start of first-line chemotherapy before index line is reported. Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line).

    The reported types of biological samples are:

    • Tissue, Histological sample (solid biopsy);
    • Cytological sample, Blood (liquid biopsy).

    Measured: At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start17 Dec 2019
  3. Primary completion22 Jul 2021
  4. Study completion22 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
462 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04179890
Sponsor's protocol ID
1200-0316
Acronym
UpSwinG
Status last verified
Jul 2022
First submitted
26 Nov 2019
Last updated
25 May 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Publications

  • Popat S, Hsia TC, Hung JY, Jung HA, Shih JY, Park CK, Lee SH, Okamoto T, Ahn HK, Lee YC, Sato Y, Lee SS, Mascaux C, Daoud H, Marten A, Miura S. Tyrosine Kinase Inhibitor Activity in Patients with NSCLC Harboring Uncommon EGFR Mutations: A Retrospective International Cohort Study (UpSwinG). Oncologist. 2022 Apr 5;27(4):255-265. doi: 10.1093/oncolo/oyac022.

    PubMed 35274704

Questions about this trial

What is this clinical trial studying?

An observational study of Non-squamous, Non-Small Cell Lung Cancer, run by Boehringer Ingelheim at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) (time frame: Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04179890, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.

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