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Non Small Cell Lung CancerPhase 4TEMPLE-2NCT05785208

Efficacy Study of Osimertinib in Treatment-naïve Patients With EGFR Mutant NSCLC According to TP53 Mutational Status.

A Phase 4 study testing Osimertinib in people with Non Small Cell Lung Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 11 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, biomarker-driven, open-label, clinical trial of osimertinib in treatment- naïve patients with EGFR mutant NSCLC, to evaluate the efficacy of osimertinib according to the TP53 mutational status. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Osimertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
11 sitesItaly
Study dates
28 Jun 2022to 31 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

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

Who may be able to join

  • Provision of informed consent prior to any study specific procedures.
  • Patients (male/female) must be > 18 years of age.
  • Locally advanced or metastatic EGFR mutant NSCLC, not amenable to curative surgery or radiotherapy with confirmation of the presence of EGFR exon 19 deletion or exon 21 p.L858R.
  • Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow central analysis.
  • Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with osimertinib. Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy) if at least 6 months has elapsed between the end of chemotherapy and enrolment.
  • World Health Organization (WHO) performance status 0-2.
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  • Patients must have a life expectancy ≥ 12 weeks.
  • Females should be using adequate contraceptive measures, should not be breastfeeding and must have a negative pregnancy test prior to start of dosing if of child- bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
  • Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
  • Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.
  • Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
  • Male patients should be willing to use barrier contraception.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.

Who cannot join

  • Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site).
  • Previous treatment with osimertinib or other drugs targeting EGFR.
  • Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.
  • Patients currently receiving (or unable to adequately stop use prior to receiving the first dose of study treatment) medications or herbal supplements included in Annex 6 (Guidance Regarding Potential Interactions with Concomitant Medications).
  • Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy.
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
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  • Patients with spinal cord compression, symptomatic and unstable brain metastases except for those patients who have completed definitive therapy, and have had a stable neurological status for at least 2 weeks after completion of definitive therapy. Patients may be on corticosteroids to control brain metastases if they have been on a stable dose for 2 weeks (14 days) prior to the start of study treatment and are clinically asymptomatic.
  • Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD.
  • Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  • Absolute neutrophil count <1.5 x 109/L.
  • Platelet count <100 x 109/L.
  • Haemoglobin <90 g/L.
  • Alanine aminotransferase >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases.
  • Aspartate aminotransferase >2.5 times ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases.
  • Total bilirubin >1.5 times ULN if no liver metastases or >3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.
  • Creatinine >1.5 times ULN concurrent with creatinine clearance <50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.
  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (QTc using Fredericia's formula) > 470 msec.
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, and second degree heart block).
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including serum/plasma potassium < LLN, serum/plasma magnesium < LLN, and serum/plasma calcium <LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.
  • Active second malignancy; i.e., patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment. Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enrol in the trial provided all chemotherapy was completed > 6 months prior and/or bone marrow transplant > 2 years prior to first day of study treatment.
  • Patients with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient's capacity to participate in the study.
  • History of hypersensitivity to osimertinib (or drugs with a similar chemical structure or class to osimertinib) or any excipients of these agents.
  • Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
  • Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

11 sites in 1 country.

Emilio Bria, Professor contact

0630155202 ext. +39

emilio.bria@policlinicogemelli.it

11 sites in 1 country

Italy11 sites, 1 recruiting

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti

    Ancona, 60020

    Suspended

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124

    Suspended

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

    Suspended

  • Ospedale Universitario di Parma

    Parma, 44129

    Suspended

  • Ospedale San Camillo de Lellis

    Rieti, 02100

    Suspended

  • Università Policlinico Tor Vergata

    Rome, 00133

    Suspended

  • Policlinico Umberto I

    Rome, 00161

    Suspended

  • Fondazione Policlinico Gemelli IRCCS

    Rome, 00168

    Emilio Bria, Professor, 0630155202 ext. +39, emilio.bria@policlinicogemelli.it

    Recruiting

  • Ospedale San Giovanni-Addolorata

    Rome, 00184

    Suspended

  • Ospedale San Luigi

    Turin, 10043

    Suspended

  • Università degli Studi di Verona

    Verona, 37129

    Suspended

Other trials in Italy

About this study

This is a prospective, biomarker-driven, open-label, clinical trial of osimertinib in treatment- naïve patients with EGFR mutant NSCLC, to evaluate the efficacy of osimertinib according to the TP53 mutational status.

Being tested
Osimertinib
Keywords
TP53, EGFR, NSCLC, Osimertinib
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.

  • OsimertinibDrug

    Osimertinib will be administered at a dose of 80 mg daily until disease progression

Study groups in NCT05785208
Study groupRoleWhat they receive
ARM A: TP53 wilde-typeExperimentalParticipants will receive osimertinib 80 mg once daily until disease progression or unacceptable toxicity.
Receives: Drug: Osimertinib
ARM B: TP53 mutantExperimentalParticipants will receive osimertinib 80 mg once daily until disease progression or unacceptable toxicity.
Receives: Drug: Osimertinib

What is being measured

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

  1. Progression-Free Survival (PFS) According to RECIST v1.1

    PFS is defined as the time from randomization until the date of objective disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death (by any cause) in the absence of progression, whichever comes first.

    Measured: 24 months

Secondary outcomes (7)

  1. Overall Survival (OS)

    Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

    Measured: 24 months

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) using RECIST v1.1 criteria.

    Measured: 24 months

  3. Disease Control Rate (DCR)

    DCR is define as the percentage of patients who achieve complete response (CR), partial response (PR) or stable disease (SD)

    Measured: 24 months

  4. Duration of Response (DoR)

    DoR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR using RECIST v1.1 criteria.

    Measured: 24 months

  5. Incidence and Severity of Adverse Events (AEs) according to CTCAE V5.0

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: 24 months

  6. Time to Central Nervous System (CNS) progression

    Time to CNS progression is defined as the time from randomization until the date of objective disease progression in the CNS using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: 24 months

  7. Objective Response Rate (ORR) in the Central Nervous System (CNS)

    ORR in the CNS is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) for CNS lesions using RECIST v1.1 criteria.

    Measured: 24 months

Timeline

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

  1. First posted27 Mar 2023
  2. Study start28 Jun 2022
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05785208
Sponsor's protocol ID
4273
Acronym
TEMPLE-2
Status last verified
Mar 2023
First submitted
14 Mar 2023
Last updated
27 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Osimertinib in people with Non Small Cell Lung Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 11 sites in Italy.

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 14 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Emilio Bria, Professor (0630155202 ext. +39, emilio.bria@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) According to RECIST v1.1 (time frame: 24 months). 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 NCT05785208.

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 27 Mar 2023.

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